INSYTE AUTOG BC WING PNK 20GA X1.16IN
Report
- Report Number
- 1710034-2024-01472
- Event Type
- Malfunction
- Date Received
- December 11, 2024
- Date of Event
- November 14, 2024
- Report Date
- December 19, 2024
- Manufacturer
- BECTON DICKINSON
- Product Code
- FOZ
- UDI-DI
- 00382903826346
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382634 AND LOT NUMBER 4260456 THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.
MATERIAL#: 382634, BATCH#: 4260456. IT WAS REPORTED BY CUSTOMER THAT WE HAVE FOUND A DEFECT IN 3 20 GAUGE IV CATHETERS. THE PART OF THE CATHETER THAT CONNECTS TO THE HEPLOCK IS WARPED. BECAUSE OF THIS IT WON'T CONNECT. THE IV HAS TO BE REMOVED AND THE PATIENT HAS TO BE STUCK AGAIN.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2404614 | INSYTE AUTOG BC WING PNK 20GA X1.16IN | CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS | FOZ | BECTON DICKINSON | 4260456 | 00382903826346 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |