FDA Adverse Event
Malfunction
Summary report: N
3F X 60CM SINGLE VASCU-PICC
MDR report key: 2092969
·
Received April 15, 2011
Report
- Report Number
- 2518902-2011-00033
- Event Type
- Malfunction
- Date Received
- April 15, 2011
- Date of Event
- March 9, 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 MFG RECORDS INDICATED THAT ALL DEVICE SPECS AND QUALITY REQUIREMENTS WERE SATISFIED. WHEN THE INVESTIGATION IS COMPLETED A FINAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE "CATHETER WAS NOTED TO BE LEAKING NEAR THE LUER HUB/CATHETER CLEAR EXTENSION JUNCTION."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3F X 60CM SINGLE VASCU-PICC | INFUSION CATHETER-PICC | LJS | MEDCOMP | MR17013106 | MBCK360 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 6 YR | Required Intervention | MICROCLAVE CONNECTOR |