INSYTE AUTOG BC WING PNK 20GA X1.16IN
Report
- Report Number
- 1710034-2024-01478
- Event Type
- Malfunction
- Date Received
- December 12, 2024
- Date of Event
- October 15, 2024
- Report Date
- February 5, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903826346
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
INVESTIGATION RESULTS: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382634 AND LOT NUMBER 4172507. A QUALITY NOTIFICATION RELATED TO THE REPORTED DEFECT WAS INITIATED DURING THE BUILD OF THIS LOT, HOWEVER WITHOUT A SAMPLE WE CANNOT CONFIRM THAT THIS FAILURE WAS RELATED TO THAT NOTIFICATION. BASED ON THE AVAILABLE INFORMATION, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
MATERIAL: 382634. BATCH#: 4172507. IT WAS REPORTED BY THE CUSTOMER THAT WHEN ADVANCED, THE CATHETER SECTION SPLIT APART FROM THE NEEDLE. NO PATIENT HARM.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2152217 | INSYTE AUTOG BC WING PNK 20GA X1.16IN | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON DICKINSON | 4172507 | 00382903826346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |