BD INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2025-01643
- Event Type
- Malfunction
- Date Received
- October 23, 2025
- Date of Event
- October 3, 2025
- Report Date
- December 19, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903825349
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- 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 382534 AND LOT NUMBER 5120994. 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.
THE COMPLAINT OF RETRACTION ISSUES WITH THE NEEDLE AND BLOOD FLOWING THROUGH THE BLOOD CONTROL VALVE COULD NOT BE CONFIRMED FROM THE UNIT PACKAGING THAT WAS PROVIDED FOR INVESTIGATION. THE PACKAGING WAS RECEIVED WITHOUT THE DEVICE. NO DAMAGE OR DEFECTS WERE IDENTIFIED ON THE PACKAGING. AS THE PACKAGING WAS UNRELATED TO THE COMPLAINT, THE COMPLAINT WAS INCONCLUSIVE AS NO DEVICE WAS PROVIDED FOR INVESTIGATION. A REVIEW OF THE INSPECTION RECORDS AND QUALITY/MANUFACTURING CONTROLS FOR THE IMPLICATED LOT INDICATED NO RELATED ISSUES WITH THE MANUFACTURING PROCESS. MANUFACTURING CONTROLS ARE IN PLACE TO MITIGATE THE OCCURRENCE OF THIS TYPE OF FAILURE. THE COMPLAINT HAS BEEN DOCUMENTED AND WILL CONTINUE TO BE MONITORED AS PART OF ONGOING EFFORTS TO IDENTIFY POTENTIAL MANUFACTURING RELATED ISSUES. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY.
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO NEW INFORMATION.
NO NEW INFORMATION.
IT WAS REPORTED THAT THE BD INSYTE AUTOG BC PNK 20GA X 1.16IN HAD A NEEDLE RETRACTION FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 382534, BATCH#: 5120994. IT WAS REPORTED BY CUSTOMER THAT "AUTOGUARD PACKAGING IS NOT SEALED PROPERLY." AUTOGUARD PACKAGING IS NOT SEALED PROPERLY. ADDITIONAL INFORMATION PROVIDED: MORNING! THAT IS NOT THE MESSAGE THAT WAS SENT. I HAVE ATTACHED THE EMAILS, PICTURES AND THE LOT NUMBERS. THIS MORNING, I RECEIVED FEEDBACK FROM SEVERAL RNS THAT THE 18 & 20G INSYTE ARE NOT RETRACTING THE NEEDLE. IN ADDITION, THE ONCE WAY VALVE WAS NOT FUNCTIONING CORRECTLY, CAUSING BLOOD TO FLOW FREELY WHICH IS NOT NORMAL ONE OF THE STAFF REPORTED THAT THE 20G INSYTE WAS NOT RETRACTING NORMALLY, ALTHOUGH AFTER PUSHING THE BUTTON SEVERAL TIMES IT MOSTLY RETRACTED. HERE IS A PICTURE OF TWO18G INSYTE THAT DID NOT RETRACT AT ALL. THIS POSES A HUGE CONCERN FOR NEEDLE STICKS. THE FIRST LOT NUMBERS DISCOVERED WERE 5129024 (18G), 5120110 (18G), 5120994 (20G).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2777743 | BD INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5120994 | 00382903825349 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |