FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1001468
·
Received February 19, 2008
Report
- Report Number
- 1710034-2008-00018
- Event Type
- Other
- Date Received
- February 19, 2008
- Date of Event
- February 3, 2008
- Report Date
- February 5, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ATTEMPTS HAVE BEEN MADE TO OBTAIN ADD'L INFO. THE SAMPLE WAS DISCARDED BY THE HOSPITAL. UPON COMPLETION OF THE NO SAMPLE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 18 FEBRUARY 2008.
Description of Event or Problem · 1
AFTER INSERTING IV CATHETER, THE CATHETER WOULD NOT RETRACT INTO THE SHIELD AND RESULTED IN A NEEDLE STICK INJURY.
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 |