Section D Flashcards
In what instance would products reported in section D result in us having to record something in section C?
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.
What is Section D1?
Brand Name [Auto Populated from QMS]; trade or proprietary name of the deivce or product. {think Frank Lucas}
Where can the trade or propriety name of the medical device be found?
- on a label attached to the durable device
- on a package of a disposible device
- in labeling materials of an implanatble device
What goes in Section D2a? Give an example
- 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]
What is Section 2b?
Procode
What is the Procode?
The FDA assigned Product Classification Code
How can the Procode be identified?
Using the Product Classification Database search page at http://www.accessdata.fda.gov/scripts/cdrh/ cfdocs/cfPCD/classification.cfm
What is Section D3?
D3: Manufacturer Name, City and State
What information goes in Section D4?
D4: Model #, Catalog #, Serial #, Lot #, Expiration date, Unique Device Identifier (UDI) #
What’s special about the serial number?
it’s assigned by the manufacturer and should be specific to each device
Where can all the numbers required for section D4 be found?
They can be printed on the device, its label, or accompanying packaging material. Also, in the manufacturers catalog
What is the UDI #, and where can it be found?
- UDI # = Unique Device Identifier #
- The number is located below the barcode
The UDI begins with one of three elements, which are they?
(01)
+
=
What is Section D6a?
Was the device implanted, give date
What was Section 6b?
Was the device explanted, give date
What is Section D7a?
D7a: Is this a Single-use Device that was Reprocessed and Reused on a Patient
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?
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.
What is Section D8?
D8: Is this device ever serviced by a Third Party?
What is Section D9?
D9: Device Availability
What information goes in Section D9?
- 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
What is Section D10?
D10: Concomitant Medical Products and Therapy Dates
What is Section D2?
Type of Device
What is Section D4? [On the Form]
Additional Device Information
What information goes in D10?
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
