FDA Adverse Event
Malfunction
Summary report: N
INSYTE AUTOGUARD
MDR report key: 25000935
·
Received April 27, 2026
Report
- Report Number
- 1710034-2026-00470
- Event Type
- Malfunction
- Date Received
- April 27, 2026
- Date of Event
- April 8, 2026
- Report Date
- April 15, 2026
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903825370
- PMA / PMN Number
- SEE H.11
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
G.4. K201075; K251654. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE BLOOD CONTROL FEATURE DID NOT WORK. A CUSTOMER REACHED OUT TO LET US KNOW THAT ITEMS 382537 AND 382523 ARE HAVING ISSUES WITH BLOOD CONTROL. ALTHOUGH BOTH ITEMS ARE LABELED AS BLOOD CONTROL, IT WAS REPORTED THAT BLOOD WAS GETTING EVERYWHERE DURING USE. THE LOT NUMBERS AND EXPIRATION DATES FOR THE ITEMS IN QUESTION ARE BELOW. PLEASE ADVISE ON HOW TO PROCEED. NO NEGATIVE OUTCOME, HOWEVER PRODUCT DID NOT PERFORM AS ADVERTISED AS THE BLOOD POURED OUT AFTER NEEDLE WAS TAKEN OUT AND WAS NOT BLOOD CONTROLLED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256317 | INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 5168802 | 00382903825370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |