Section D

Question 1

In what instance would products reported in section D result in us having to record something in section C?

Answer 1

For in vitro diagnostic products and radiation therapy products that are reported in section D, we must use the section C4 [Treatment/Therapy Start and Stop Dates] to record the date that diagnostic tests are performed.

Question 2

What is Section D1?

Answer 2

Brand Name [Auto Populated from QMS]; trade or proprietary name of the deivce or product. {think Frank Lucas}

Question 3

Where can the trade or propriety name of the medical device be found?

Answer 3

• on a label attached to the durable device
• on a package of a disposible device
• in labeling materials of an implanatble device

Question 4

What goes in Section D2a? Give an example

Answer 4

• The generic or common name of the medical device.
• Heart Pacemaker, Urological Catheter [Correct]
• catheter [wrong; too broad/generic]
• Flo-Easy Catheter [wrong; Brand Name]

Question 5

What is Section 2b?

Answer 5

Procode

Question 6

What is the Procode?

Answer 6

The FDA assigned Product Classification Code

Question 7

How can the Procode be identified?

Answer 7

Using the Product Classification Database search page at http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfPCD/classification.cfm

Question 8

What is Section D3?

Answer 8

D3: Manufacturer Name, City and State

Question 9

What information goes in Section D4?

Answer 9

D4: Model #, Catalog #, Serial #, Lot #, Expiration date, Unique Device Identifier (UDI) #

Question 10

What’s special about the serial number?

Answer 10

it’s assigned by the manufacturer and should be specific to each device

Question 11

Where can all the numbers required for section D4 be found?

Answer 11

They can be printed on the device, its label, or accompanying packaging material. Also, in the manufacturers catalog

Question 12

What is the UDI #, and where can it be found?

Answer 12

• UDI # = Unique Device Identifier #
• The number is located below the barcode

Question 13

The UDI begins with one of three elements, which are they?

Answer 13

(01)
+
=

Question 14

What is Section D6a?

Answer 14

Was the device implanted, give date

Question 15

What was Section 6b?

Answer 15

Was the device explanted, give date

Question 16

What is Section D7a?

Answer 16

D7a: Is this a Single-use Device that was Reprocessed and Reused on a Patient

Question 17

If the Original Equipment Manufacturer [OEM] is unable to determine if their single use device was reprocessed and reused on a PT, how should this be stated on the report?

Answer 17

The OEM should enter “UNK” in Block D8, and in Block H11 (Additional Manufacturer Narrative), describe the efforts made to obtain the information and any responses.

Question 18

What is Section D8?

Answer 18

D8: Is this device ever serviced by a Third Party?

Question 19

What is Section D9?

Answer 19

D9: Device Availability

Question 20

What information goes in Section D9?

Answer 20

• Indicate whether the device was returned to the manufacturer, if so, give the date.
• Indicate if the device is available for evaluation by the manufacturer
• DO NOT SEND THE DEVICE TO THE FDA

Question 21

What is Section D10?

Answer 21

D10: Concomitant Medical Products and Therapy Dates

Question 22

What is Section D2?

Answer 22

Type of Device

Question 23

What is Section D4? [On the Form]

Answer 23

Additional Device Information

Question 24

What information goes in D10?

Answer 24

List and provide product names and therapy dates for any other medical products (drugs, biologics, including human cells, tissues, and cellular and tissue-based products (HCT/ Ps), or medical devices, etc.) that the patient was using at the time of the event. Do not include products used to treat the event

Question 25

What’s Section D5?

Answer 25

D5: Operator of Device

Question 26

What information goes in D5?

Answer 26

Indicate the type (not the name) of person operating or using the suspect medical device on the patient at the time of the event as follows:
- Health Professional = physician, nurse, respiratory therapist, etc.
- Patient/Consumer = person being treated, parent/ spouse/friend of the patient
- Other = nurses aide, orderly, etc.

Question 27

If either Section D8 (Was this device ever serviced by a third party?) or Section 7a (Is this a single-use device that was reprocessed or reused on a PT?) which section does this change, and how?

Answer 27

If section D7a or D8 is a “Yes,” then D3 (Manufacturer name and address) may not be the OEM. It may be the company that reprocessed said single-use device or the User Facility that (hospital, clinic) reprocessed the device