FDA Adverse Event
Injury
Summary report: N
BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 935087
·
Received October 29, 2007
Report
- Report Number
- 1710034-2007-00101
- Event Type
- Injury
- Date Received
- October 29, 2007
- Date of Event
- September 26, 2007
- Report Date
- October 16, 2007
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: WE WERE UNABLE TO PERFORM A ROOT CAUSE ANALYSIS AS THE ACTUAL SAMPLE WAS NOT RETURNED AND NO REPRESENTATIVE UNITS WERE RETURNED FOR EVAL. THE DEVICE HISTORY WAS REVIEWED FOR REPORTED LOT NUMBER 7080167 AND NO IRREGULARITIES WERE NOTED DURING THE LOT'S MFR. DATE SUBMITTED: 26 OCTOBER 2007.
Description of Event or Problem · 1
THE CATHETER WAS FOUND TO BE BROKEN AND WAS SURGICALLY REMOVED FROM THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER | PERCUTANEOUS CATHETER | LJS | BECTON DICKINSON INFUSION THERAPY SYSTEMS | NA | 7080167 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 MO | Other |