FDA Adverse Event
Malfunction
Summary report: N
1.9FX50CM VASCU-PICC
MDR report key: 2093092
·
Received April 15, 2011
Report
- Report Number
- 2518902-2011-00038
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- March 27, 2011
- Report Date
- April 11, 2011
- Manufacturer
- MEDCOMP
- Product Code
- LJS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION HAS BEEN INITIATED. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETE, A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE "PICC LINE BROKE AT THE JUNCTION OF THE WHITE LUER HUB AND CLEAR CATHETER TUBING EXTENSION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.9FX50CM VASCU-PICC | INFUSION CATHETER-PICC | LJS | MEDCOMP | MR17011101 | MBCH680 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 3 MO | Required Intervention | MICROCLAVE CONNECTOR |