FDA Adverse Event
Other
Summary report: N
BD L-CATH PERIPHERALLY INSERTED CENTRAL CATHETER
MDR report key: 1213713
·
Received October 22, 2008
Report
- Report Number
- 1710034-2008-00129
- Event Type
- Other
- Date Received
- October 22, 2008
- Date of Event
- August 20, 2008
- Report Date
- September 25, 2008
- Manufacturer
- BECTON DICKINSON INFUSION THERAPY SYSTEMS
- Product Code
- LJS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE SAMPLE WAS RECEIVED IN 2008, AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 22 OCTOBER 2008.
Description of Event or Problem · 1
THE CATHETER WAS PLACED IN A PREMATURE INFANT IN 2008. THE NURSE NOTICED A LEAK AND TRIED TO REPAIR THE CATHETER, ADDITIONAL LEAKING NEAR THE INSERTION SITE WAS NOTED. THE NURSE THEN DECIDED TO REMOVE THE CATHETER. DURING THE REMOVAL PROCESS SLIGHT RESISTANCE WAS MET AND A WARM COMPRESS WAS APPLIED TO THE ARM. THE NURSE INDICATED THAT THE CATHETER DISINTEGRATED AND LOOKED LIKE A LIMP NOODLE. X-RAYS WERE TAKEN AND THE CATHETER WAS SURGICALLY REMOVED.
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 | 8007280 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 1 MO | Other | DOPAMINE AT 12 MCG/KG/MIN| FENTANYL AT 2 MCG/KG/HR| TPN D 18% WITH 3% AMINO ACIDS |