FDA Adverse Event
Malfunction
Summary report: N
SINGLE LUMEN INSERTION TRAY
MDR report key: 2033758
·
Received March 23, 2011
Report
- Report Number
- 1317749-2011-00105
- Event Type
- Malfunction
- Date Received
- March 23, 2011
- Date of Event
- January 21, 2011
- Report Date
- March 8, 2011
- Manufacturer
- COVIDIEN
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011, THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE CUSTOMER REPORTS A SINGLE LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) WAS PLACED ON (B)(6) 2011 IN THE RIGHT AXILLA, CAUSING PLEURAL EFFUSION. ON (B)(6) 2011 THE PICC WAS REMOVED. PERIPHERAL ACCESS WAS OBTAINED. POST EVENT THE PATIENT STATUS WAS CRITICAL AND HIGH FREQUENCY OSCILLATORY VENTILATION WAS USED FOR SEVERAL DAYS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SINGLE LUMEN INSERTION TRAY | PICC | LJS | COVIDIEN | 43309 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |