FDA Adverse Event
Other
Summary report: N
SAF-T-INTIMA SHIELDED IV CATHETER
MDR report key: 1193529
·
Received October 8, 2008
Report
- Report Number
- 9610847-2008-00078
- Event Type
- Other
- Date Received
- October 8, 2008
- Date of Event
- September 6, 2008
- Report Date
- September 23, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- FOZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE IS NOT AVAILABLE FOR THE INVESTIGATION. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER WAS INSERTED IN 2008. DURING THE NIGHT OF THE FOLLOWING DAY, THE PT PRESENTED SIGNS OF SEPTIC SHOCK: RED AND WARM AT THE LEFT OF THE SIDE, FEVER 100.4 DEGREES FAHRENHEIT. THE CATHETER WAS REMOVED. ELEVEN DAYS AFTER, THE LESION CONTINUED TO EVOLVE BECAUSE THE LEFT SIDE OF THE ABDOMEN WAS ABSCESSED.
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 | Other |