FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1121345
·
Received August 11, 2008
Report
- Report Number
- 1710034-2008-00097
- Event Type
- Other
- Date Received
- August 11, 2008
- Date of Event
- July 24, 2008
- Report Date
- July 24, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED ON 01 AUGUST 2008 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. WE ARE ATTEMPTING TO OBTAIN ADDITIONAL INFORMATION.
Description of Event or Problem · 1
WHILE INSERTING, THE CATHETER COULDN'T ADVANCE. THE TIP OF THE CATHETER WAS MISSING AND WAS JAGGED ON END. THE CATHETER HAD TO BE SURGICALLY REMOVED.
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 |