FDA Adverse Event
Other
Summary report: N
BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 955709
·
Received April 27, 2007
Report
- Report Number
- 1710034-2007-00026
- Event Type
- Other
- Date Received
- April 27, 2007
- Date of Event
- April 4, 2007
- Report Date
- April 24, 2007
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCLUSIONS - A ROOT CAUSE ANALYSIS COULD NOT BE PERFORMED AS THE SAMPLE WAS NOT RETURNED FOR EVALUATION. WE WERE UNABLE TO REVIEW THE DEVICE HISTORY AS A LOT NUMBER WAS NOT PROVIDED. ATTEMPTS TO RETRIEVE ADDITIONAL INFORMATION REGARDING THE INCIDENT WENT UNANSWERED. IF THE SAMPLE BECOMES AVAILABLE AND RETURNED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
THE CATHETER BROKE WHILE INDWELLING.
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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Other |