Q-SYTE CLOSED LUER ACCESS DEVICE
Report
- Report Number
- 1710034-2025-00999
- Event Type
- Malfunction
- Date Received
- June 12, 2025
- Date of Event
- May 17, 2025
- Report Date
- June 25, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FPA
- UDI-DI
- 00382903851003
- PMA / PMN Number
- K013621
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 4213935 . 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.
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
NO ADDITIONAL INFORMATION.
DESCRIPTION: WHEN CONTINUOUSLY PUMPING NIKETHAMIDE INJECTION, THE CONNECTOR BROKE AND CAUSED LEAKAGE. QUANTITY: 2 TUBES, SAMPLES CANNOT BE RETURNED, PHOTOS CANNOT BE PROVIDED,
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 342854 | Q-SYTE CLOSED LUER ACCESS DEVICE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4213935 | 00382903851003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |