FDA Adverse Event
Summary report: N
SAF-T-INTIMA SHIELDED IV CATHETER
MDR report key: 1012361
·
Received March 10, 2008
Report
- Report Number
- 9610847-2008-00021
- Date Received
- March 10, 2008
- Report Date
- March 5, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFO. UPON CO COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE PRN LOOSENED FROM THE SAF-T-INTIMA DEVICE AND REMAINED ATTACHED TO THE TELESCOPING SHIELD DURING THE NEEDLE REMOVAL; THIS WENT UNNOTICED UNTIL THE NEXT NURSE VISIT. MEDICATION HAD LEAKED OUT OF THE ADMINISTRATION SET. THE DEVICE WAS IN USE BY A TERMINALLY ILL PATIENT AT HOME. THE PT WAS UNHARMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SAF-T-INTIMA SHIELDED IV CATHETER | INTRAVASCULAR CATHETER | FOZ | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |