FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1062846
·
Received June 18, 2008
Report
- Report Number
- 1710034-2008-00072
- Event Type
- Other
- Date Received
- June 18, 2008
- Date of Event
- March 21, 2008
- Report Date
- June 2, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 18 JUNE 2008.
Description of Event or Problem · 1
IV WAS INSERTED IN 2008, IN THE LEFT ANTECUBITAL FOSSA. THE NURSE WAS DISCONTINUING THE IV TWO DAYS LATER, WHEN SHE NOTICED THE CATHETER WAS BROKEN. THE CATHETER WAS SUCCESSFULLY REMOVED SURGICALLY WITH NO OTHER PATIENT 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 |