FDA Adverse Event
Other
Summary report: N
FIST PICC PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 1172785
·
Received September 17, 2008
Report
- Report Number
- 1710034-2008-00118
- Event Type
- Other
- Date Received
- September 17, 2008
- Date of Event
- August 28, 2008
- Report Date
- August 29, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
RECEIVED ONE USED UNIT IN 2008, THAT IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 2008.
Description of Event or Problem · 1
THE CATHETER WAS INSERTED INTO THE PT IN 2008. AND ON THE SECOND DAY, WHEN THE PT WAS SENT TO THE ICU AFTER SURGERY, THE NURSE FOUND THE CATHETER BROKEN NEAR OVAL DISK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIST PICC PERIPHERALLY INSERTED CENTRAL CATHETER | PERCUTANEOUS CATHETER | LJS | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 7262028 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |