INSYTE AUTOGUARD
Report
- Report Number
- 1710034-2026-00329
- Event Type
- Malfunction
- Date Received
- March 25, 2026
- Date of Event
- March 18, 2026
- Report Date
- April 22, 2026
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903825233
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
G.4. K201075; K251654.
INVESTIGATION SUMMARY: ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE INFORMATION. A COMPLAINT HISTORY CHECK WAS PERFORMED, AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF NEEDLE RETRACTION FAILURE WITH LOT 5210685 REGARDING ITEM 382523. DHR NUMBER 5210685 HAS BEEN REVIEWED. NO RELATED QUALITY ISSUES OR PROCESS DEVIATIONS WERE FOUND DURING THE MANUFACTURE OF THE SUBASSEMBLY LOT AND PACKAGING LINE. A REVIEW OF THE APPLICABLE RISK DOCUMENTS INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.
IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT. IV NEEDLE DID NOT RETRACK WHEN WHITE BUTTON PRESSED TO ENGAGED SAFETY. ADDITIONAL INFORMATION 3/23/2026: PER STAFF: NO PATIENT HARM. THESE WERE NEAR MISS EVENTS THAT HAD THE POTENTIAL TO CAUSE INJURY TO EMPLOYEES
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 556468 | INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5210685 | 00382903825233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |