BD INSYTE AUTOGUARD WINGED
Report
- Report Number
- 1710034-2025-01216
- Event Type
- Malfunction
- Date Received
- July 22, 2025
- Date of Event
- July 9, 2025
- Report Date
- August 1, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RP
- 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.
A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 381923 AND LOT NUMBER 4222720. 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.
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS NOTED THAT USER EXPERIENCED DIFFICULTY OPERATING THE MECHANISM OF THE ITEM WHEN PRESSING THE BUTTON. ADDITIONALLY, A DELAY IN NEEDLE ENCAPSULATION WAS OBSERVED, THIS IS CONSIDERED AS MANUFACTURING DEFECT. IMPACT TO PATIENT, HCP, USER OR OTHER? NO.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2037218 | BD INSYTE AUTOGUARD WINGED | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4222720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |