FDA Adverse Event
Other
Summary report: N
BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM
MDR report key: 2090839
·
Received May 6, 2011
Report
- Report Number
- 9610847-2011-00028
- Event Type
- Other
- Date Received
- May 6, 2011
- Date of Event
- April 21, 2011
- Report Date
- April 25, 2011
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS AVAILABLE FOR EVAL. ADD'L INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).
Description of Event or Problem · 1
THE TUBING BROKE BELOW THE WINGED INSERTER DURING STYLET REMOVAL. THERE WAS NO HARM TO THE PT OR CLINICIAN AS A RESULT OF THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD SAF-T-INTIMA CLOSED IV CATHETER SYSTEM | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |