FDA Adverse Event
Malfunction
Summary report: N
INSYTE AUTOGUARD
MDR report key: 22956954
·
Received September 3, 2025
Report
- Report Number
- 1710034-2025-01447
- Event Type
- Malfunction
- Date Received
- September 3, 2025
- Date of Event
- August 15, 2025
- Report Date
- September 11, 2025
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
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.
Additional Manufacturer Narrative · 0
AS NO PHYSICAL SAMPLE, PICTURE SAMPLE, OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A ROOT CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.
Description of Event or Problem · 0
¿THE EXAMPLE IS THE PUSH BUTTON NOT DISENGAGING THE NEEDLE ON THE BD INSYTE AUTOGUARD. A SMALL VOLUME OF LOTS WERE RECALLED, BY WE CONTINUE TO HAVE SAME ISSUE WITH DIFFERENT LOTS.¿.
Description of Event or Problem · 0
NO NEW INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1735130 | INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |