FDA Adverse Event
Other
Summary report: N
FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 1121346
·
Received August 11, 2008
Report
- Report Number
- 1710034-2008-00106
- Event Type
- Other
- Date Received
- August 11, 2008
- Date of Event
- July 12, 2008
- Report Date
- July 17, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED. RECEIVED ONE UNIT BROKEN IN TWO PIECES ON JULY 28, 2008 AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).
Description of Event or Problem · 1
THE CATHETER WAS INSERTED FOR TWO WEEKS WHEN THE INCIDENT WAS DISCOVERED. ON (B) (6) THE NURSE SAID THE CATHETER LEAKED. WHEN THE SAMPLE WAS RECEIVED ON JULY 28, 2008, IT WAS DETERMINED THAT THE CATHETER WAS BROKEN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FIRST PICC PERIPHERALLY INSERTED CENTRAL CATHETER | PERCUTANEOUS CATHETER | LJS | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 6226208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |