BD INSYTE AUTOGUARD WINGED
Report
- Report Number
- 1710034-2025-00298
- Event Type
- Malfunction
- Date Received
- February 21, 2025
- Date of Event
- February 7, 2025
- Report Date
- April 11, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- UNK
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- 003
Narratives
TYPO CORRECTION FOR INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 3 UNSEALED AND 1 SEALED 22 GA X 1.00 IN. INSYTE AUTOGUARD WINGED UNITS FROM LOT NUMBER 4222720. YOUR REPORT THAT THE NEEDLE FAILED TO RETRACT COULD NOT BE CONFIRMED. THREE SAMPLES WERE RECEIVED IN OPEN PACKAGING AND THE NEEDLES WERE FULLY RETRACTED. ONE UNIT WAS RECEIVED IN SEALED PACKAGING. A FUNCTIONAL TEST SHOWED THAT THE NEEDLES WOULD FULLY RETRACT, AND NO DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED SAMPLES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 3 UNSEALED AND 1 SEALED 22GA X 1.00IN. INSYTE AUTOGUARD WINGED UNITS FROM LOT NUMBER 4222720. YOUR REPORT THAT THE NEEDLE FAILED TO RETRACT COULD NOT BE CONFIRMED. THREE SAMPLES WERE RECEIVED IN OPEN PACKAGING AND THE NEEDLES WERE FULLY RETRACTED. ONE UNIT WAS RECEIVED IN SEALED PACKAGING. A FUNCTIONAL TEST SHOWED THAT THE NEEDLES WOULD FULLY RETRACT, AND NO DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED SAMPLES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED SAMPLES SUBMITTED FOR EVALUATION. BD RECEIVED 3 UNSEALED AND 1 SEALED 22GA X 1.00IN. INSYTE AUTOGUARD WINGED UNITS FROM LOT NUMBER 4222720. YOUR REPORT THAT THE NEEDLE FAILED TO RETRACT COULD NOT BE CONFIRMED FROM THE FOUR 24GA INSYTE-N AUTOGUARD UNITS FROM LOT: 4208538. THREE SAMPLES WERE RECEIVED IN OPEN PACKAGING AND THE NEEDLES WERE FULLY RETRACTED. ONE UNIT WAS RECEIVED IN SEALED PACKAGING. A FUNCTIONAL TEST SHOWED THAT THE NEEDLES WOULD FULLY RETRACT, AND NO DAMAGE OR DEFECTS WERE NOTED ON THE RETURNED SAMPLES. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. HOWEVER, A TREND HAS BEEN IDENTIFIED FOR THE REPORTED FAILURE AND CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD INSYTE AUTOGUARD WINGED NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DATE OF INCIDENT (YYYY-MM-DD): (B)(6) 2025 TYPE OF INCIDENT/PROBLEM: FAILURE LEVEL OF HARM: HAZARD ¿ CLOSE CALL. INCIDENT DETAILS: MULTIPLE ISSUES WITH NEEDLE NOT RETRACTING ON BD INSYTE AUTOGUARD WINGED NEEDLES. STAFF HAVE HAS MULTIPLE ISSUES WHEN PRESSING THE BUTTON THE NEEDLE DOES NOT RETRACT. PRESENTS SIGNIFICANT SAFETY RISK OF NEEDLE POKE. I HAVE 7 NEEDLES, ALL THE SAME LOT NUMBER, FROM FEB 7 PROCEDURE: IV INITIATION.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1619829 | BD INSYTE AUTOGUARD WINGED | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 4222720 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |