INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2025-01881
- Event Type
- Malfunction
- Date Received
- November 26, 2025
- Date of Event
- November 11, 2025
- Report Date
- January 22, 2026
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903826230
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- RISK MANAGER
- Health Professional
- N
Narratives
OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORT OF COMPLICATIONS DURING THE INSERTION PROCESS COULD NOT BE CONFIRMED. SEVEN 22G INSYTE AUTOGUARD DEVICES WERE PROVIDED FOR INVESTIGATION. TWO UNITS WERE FROM LOT NUMBER 4080058 AND FIVE UNITS WERE FROM LOT NUMBER 5188475. A FUNCTIONAL TEST TO SIMULATE IV CATHETER INSERTION REVEALED THAT THE NEEDLE TIP PENETRATION, CATHETER TIP PENETRATION, AND CATHETER DRAG FORCES WERE WITHIN SPECIFICATION. A TEST TO LOOSEN THE CATHETER FROM THE NEEDLE AND RETRACT THE NEEDLE WITHIN THE SAFETY SHIELD REVEALED NO DAMAGE OR DEFECTS. THE NEEDLES FULLY RETRACTED AND THE RETRACTION TIME WAS WITHIN SPECIFICATION. A LEAK TEST REVEALED NO LEAKS IN THE RETURNED SAMPLES. THE AFFECTED UNITS WERE NOT RETURNED FOR INVESTIGATION.A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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.
DIFFICULTY RETRACTING NEEDLE. SERIOUS INJURY? NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2030011 | INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5188475 | 00382903826230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |