FDA Adverse Event
Other
Summary report: N
BD INSYTE AUTOGUARD SHIELDED IV CATHETER
MDR report key: 1221817
·
Received November 3, 2008
Report
- Report Number
- 1710034-2008-00137
- Event Type
- Other
- Date Received
- November 3, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 16, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED ON 10/29/2008 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETEION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER WAS INSERTED IN 2008 AND WAS FOUND TO BE BROKEN TWO DAYS LATER. THE CATHETER SEGMENT WAS FOUND AT THE BACK SIDE OF THE PATIENT. THERE WAS NO HARM TO THE PATIENT.
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 | 76 YR | Other | VISCORIN/1A| VITANEURIN/1V| DRUG: SOLITAT NO.3/500MM| SALINE| PRODUCT: JMS PLANECTA EXTENSION TUBE |