FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 2062798
·
Received April 6, 2011
Report
- Report Number
- 1710034-2011-00020
- Event Type
- Other
- Date Received
- April 6, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 24, 2011
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED 03/31/2011 AND SENT FOR DECONTAMINATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE CATHETER WAS PLACED IN THE PT'S RIGHT FEMORAL ARTERY. THE CATHETER WAS DUE TO BE REMOVED TWO DAYS AFTER INSERTION. AFTER REMOVING THE TAPE AND DRESSING, THE NURSE WENT TO REMOVE THE CATHETER AND OBSERVED THAT THE CATHETER TUBING WAS NO LONGER ATTACHED TO THE BLUE ADAPTER, AS IT HAD BROKEN IN HALF. THE CATHETER TUBING WAS STICKING OUT OF THE PT'S SKIN AND WAS REMOVED WITH NO COMPLICATIONS.
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 | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |