BD IAG BC PRO GLOBAL
Report
- Report Number
- 1710034-2024-00857
- Event Type
- Malfunction
- Date Received
- August 8, 2024
- Date of Event
- July 14, 2024
- Report Date
- September 4, 2024
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903810444
- PMA / PMN Number
- UK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
H.3. 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 381044 AND LOT NUMBER 4070007. 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.
IT WAS REPORTED THAT BD IAG BC PRO GLOBAL NEEDLE DID NOT COMPLETELY RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN RETRACKING, NEEDLE RETRACT ALL THE WAY ONLY INTO HUB WITH POTENTIAL OF NEEDLE STICK INJURY
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1562018 | BD IAG BC PRO GLOBAL | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4070007 | 00382903810444 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |