BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Report
- Report Number
- 1710034-2022-00794
- Event Type
- Malfunction
- Date Received
- December 12, 2022
- Date of Event
- November 18, 2022
- Report Date
- January 24, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS RETRACTING CAUSING DELAY IN THE SPRING MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGUARD BC ANGIOCATH NEEDLE RETRACTING. IT WAS DESCRIBED AS A DELAY IN THE SPRING MECHANISM. 20 GA 382533, LOT# 2192132.
IT WAS REPORTED THAT THE BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER WAS RETRACTING CAUSING DELAY IN THE SPRING MECHANISM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INSYTE AUTOGUARD BC ANGIOCATH NEEDLE RETRACTING. IT WAS DESCRIBED AS A DELAY IN THE SPRING MECHANISM. 20 GA 382533 LOT# 2192132.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2180955 | BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER | INTRAVENOUS CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 2192132 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |