Q-SYTE
Report
- Report Number
- 1710034-2025-01884
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- July 1, 2025
- Report Date
- December 4, 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
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 THE REPORTED ISSUE, 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.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
NO NEW INFORMATION.
ON (B)(6) 2025, AFTER ADMINISTERING AN IV INFUSION TO THE PATIENT, THE VEIN CEASED DRIPPING FOLLOWING THE CONNECTION OF THE NEEDLE-FREE CLOSED INFUSION CONNECTOR TO THE SEPTUM AT THE PORT OF THE INDWELLING NEEDLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2673025 | Q-SYTE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4213935 | 00382903851003 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |