BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE
Report
- Report Number
- 9610847-2024-00180
- Event Type
- Malfunction
- Date Received
- July 1, 2024
- Date of Event
- April 8, 2024
- Report Date
- August 20, 2024
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FPA
- UDI-DI
- 00382903851027
- PMA / PMN Number
- K013621
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385102 AND LOT NUMBER 3180511. 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 Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE CONNECTOR WAS DEFECTIVE AND LEAKED. THE PATIENT WAS TREATED WITH IV FLUIDS ON (B)(6). WHEN CONNECTING THE INFUSION, FLUID WAS FOUND TO BE LEAKING OUT, AND THE CONNECTOR WAS PROMPTLY REPLACED WITHOUT LEAKAGE.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 617719 | BD Q-SYTE EXT SET, LUER-LOK 6 IN MICRO BORE | INTRAVASCULAR ADMINISTRATION SET | FPA | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 3180511 | 00382903851027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |