FDA Adverse Event
Malfunction
Summary report: N
BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
MDR report key: 16721481
·
Received April 11, 2023
Report
- Report Number
- 1710034-2023-00404
- Event Type
- Malfunction
- Date Received
- April 11, 2023
- Date of Event
- March 24, 2023
- Report Date
- March 29, 2023
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
- Product Code
- FOZ
- UDI-DI
- 00382903814343
- PMA / PMN Number
- K201075
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF THE BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER NEEDLE WOULD NOT RETRACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE HAD MULTIPLE CATHETERS, ALL FROM LOT# 2160587, THAT DO NOT RETRACT THE NEEDLE WHEN THE BUTTON IS PRESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1107533 | BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. | 381434 | 2160587 | 00382903814343 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |