FDA Adverse Event
Malfunction
Summary report: N
BD INSYTE AUTOGUARD
MDR report key: 19004129
·
Received March 29, 2024
Report
- Report Number
- 1710034-2024-00261
- Event Type
- Malfunction
- Date Received
- March 29, 2024
- Date of Event
- March 1, 2024
- Report Date
- April 1, 2024
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814336
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
CORRECTION DUPLICATE RECORD- CANCEL MDR. SEE 1710034-2024-00225.
Additional Manufacturer Narrative · 0
H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. E1. ADDRESS INFORMATION WAS NOT PROVIDED, THEREFORE, XX WAS USED AS A PLACE HOLDER.
Description of Event or Problem · 0
NA.
Description of Event or Problem · 0
IT WAS REPORTED THAT BD INSYTE AUTOGUARD NEEDLE DID NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED INCIDENT WHERE THE NEEDLE HAS FAILED TO RETRACT. THERE WERE NO INJURIES AS A RESULT OF THE FAILURES
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2587685 | BD INSYTE AUTOGUARD | PERIPHERAL IV CATHETERS | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 3268835 | 00382903814336 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |