INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2025-02013
- Event Type
- Malfunction
- Date Received
- January 4, 2026
- Date of Event
- December 15, 2025
- Report Date
- January 22, 2026
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903825233
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 382523 AND LOT NUMBER 5253730. 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.
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
CUSTOMER QUESTION SENT 16JAN26: BLOOD EXPOSURE TO THE NURSE " IS REPORTED. WAS THE NURSE WEARING APPROPRIATE PPE? WAS THERE ANY EXPOSURE TO DAMAGED SKIN/MUCOUS MEMBRANES? IF YES, PLEASE PROVIDE ANY DIAGNOSTICS OR MEDICAL TREATMENT REQUIRED AS A DIRECT RESULT OF THE REPORTED BLOOD EXPOSURE. CUSTOMER RESPONSE: NO, IT WAS A RISK OF EXPOSURE NOT ACTUAL EXPOSURE.
CATHETER IS LEAKING OUT OF THE HUB. BLOOD EXPOSURE TO THE NURSE AND FAULTY IV NOT WORKING AS INTENDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15536 | INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5253730 | 00382903825233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |