FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 856114
·
Received May 4, 2007
Report
- Report Number
- 1710034-2007-00037
- Event Type
- Other
- Date Received
- May 4, 2007
- Date of Event
- April 24, 2007
- Report Date
- May 3, 2007
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
- Product Code
- FOZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
WE RECEIVED ONE USED CATHETER/ADAPTER UNIT FOR ANALYSIS ON 01 MAY, 2007. THE SAMPLE IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION OF THE UNIT AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
DURING REMOVAL OF THE CATHETER, THE CATHETER BROKE OFF WHILE INDWELLING. NO HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD INSYTE AUTOGUARD SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 22 YR | Other |