FDA Adverse Event
Malfunction
Summary report: N
3F X 60CM SINGLE VASCU-PICC
MDR report key: 2012224
·
Received February 2, 2011
Report
- Report Number
- 2518902-2011-00009
- Event Type
- Malfunction
- Date Received
- February 2, 2011
- Date of Event
- January 8, 2011
- Report Date
- February 2, 2011
- Manufacturer
- MEDCOMP
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A REVIEW OF THE MFG RECORDS INDICATED THAT ALL DEVICE SPECIFICATIONS AND QUALITY REQUIREMENTS WERE SATISFIED. WITHOUT AN EVALUATION OF THE DEVICE INVOLVED IN THE INCIDENT, WE ARE UNABLE TO DETERMINE THE CAUSE OR FACTORS THAT MAY HAE CONTRIBUTED TO THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CATHETER WAS NOTED TO BE LEAKING AT THE JUNCTION BETWEEN THE HARD PLASTIC HUB AND THE REINFORCED SEGMENT OF THE CATHETER. THE PT HAD A SUCCESSFUL CATHETER EXCHANGE. NO BLOOD LOSS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 3F X 60CM SINGLE VASCU-PICC | INFUSION CATHETER, PICC | LJS | MEDCOMP | MR17013106 | MBBT440 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR |