FDA Adverse Event
Malfunction
Summary report: N
L-CATH PICC SINGLE LUMEN CATHETER
MDR report key: 3062698
·
Received March 8, 2013
Report
- Report Number
- 3062698
- Event Type
- Malfunction
- Date Received
- March 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 8, 2013
- Manufacturer
- ARGON MEDICAL DEVICES, INC.
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CA, US
Narratives
Description of Event or Problem · 1
DURING ORDER TO DISCONTINUE PICC LINE FROM INFANT, THE NURSE REMOVED PICC LINE DRESSING AND NOTED THAT CATHETER SEPARATED FROM THE LAVENDER STRAIN RELIEF. THE NURSE SUCCESSFULLY REMOVED THE CATHETER LINE AND MEASURED THE CORRECT LINE DISTANCE OF 13CM. LINE WAS SAVED FOR BIOMEDICAL AND MANUFACTURER ANALYSIS.======================MANUFACTURER RESPONSE FOR PERIPHERALLY INSERTED CENTRAL CATHETER (PICC), L-CATH (PER SITE REPORTER).======================WILL RETURN TO MANUFACTURER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?PICC LINE REMOVAL.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 100525 | L-CATH PICC SINGLE LUMEN CATHETER | CATHETER | LJS | ARGON MEDICAL DEVICES, INC. | 384539 | 11029117 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 DAY |