INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2025-01644
- Event Type
- Malfunction
- Date Received
- October 23, 2025
- Date of Event
- October 2, 2025
- Report Date
- January 21, 2026
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903825448
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORTED ISSUE THAT THE NEEDLE DID NOT FULLY RETRACT WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. FIVE 18G INSYTE AUTOGUARD BC DEVICES FROM LOT #5052302 WERE PROVIDED FOR INVESTIGATION. THE SAFETY MECHANISM HAD BEEN ACTIVATED ON EACH SAMPLE. TWO NEEDLES WERE RECEIVED FULLY RETRACTED. THREE NEEDLES WERE RECEIVED WITH THE FLASH NOTCH CAUGHT ON THE BLOOD CONTROL VALVE. AFTER MANIPULATING THE IV CATHETER, THE NEEDLE ENDED UP FULLY RETRACTING WITHIN THE SAFETY SHIELD. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
OUR QUALITY ENGINEER INSPECTED THE SAMPLES SUBMITTED FOR EVALUATION. YOUR REPORTED ISSUE THAT THE NEEDLE DID NOT FULLY RETRACT WAS CONFIRMED AND THE CAUSE APPEARED TO BE MANUFACTURING RELATED. FIVE 18G INSYTE AUTOGUARD BC DEVICES FROM LOT #5052302 WERE PROVIDED FOR INVESTIGATION. THE SAFETY MECHANISM HAD BEEN ACTIVATED ON EACH SAMPLE. TWO NEEDLES WERE RECEIVED FULLY RETRACTED. THREE NEEDLES WERE RECEIVED WITH THE FLASH NOTCH CAUGHT ON THE BLOOD CONTROL VALVE. AFTER MANIPULATING THE IV CATHETER, THE NEEDLE ENDED UP FULLY RETRACTING WITHIN THE SAFETY SHIELD. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION.
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.
NO NEW INFORMATION.
AFTER THE IV CATHETER WAS INSERTED, THE NEEDLE WAS STUCK AND DID NOT RETRACT. THE NURSE WAS ABLE TO LEAVE THE CATHETER IN THE SKIN AND PULL THE NEEDLE OUT. NEEDLE STILL DID NOT RETRACT WHEN TAKEN OUT OF THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 10OCT2025. THE BUTTON DID DEPRESS IT JUST DOES NOT TRIGGER FOR THE NEEDLE TO RETRACT. THE NEEDLE EITHER RETRACTS IN SLOW MOTION OR GETS STUCK IN THE HUB OF THE IV CATHETER. I HAVE HAD AT LEAST 10 MORE OCCURRENCES OF THE SAME ISSUE SINCE THE INITIAL COMPLAINT, WITH THE SAME LOT NUMBER. THIS ISSUE HAS NOT CAUSED AN INJURY TO A PATIENT OR A NURSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1931615 | INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5052302 | 00382903825448 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |