FDA Adverse Event
Malfunction
Summary report: N
DUAL LUMEN INSERTION TRAY
MDR report key: 2082128
·
Received April 27, 2011
Report
- Report Number
- 1317749-2011-00144
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 18, 2011
- Manufacturer
- COVIDIEN
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 04/26/2011. 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 DUAL LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE CUSTOMER REPORTED THAT THE PICC WAS LEAKING. THE PICC WAS INSERTED ON (B)(6) 2011 AND WAS REMOVED ON (B)(6) 2011. THE CUSTOMER STATED THAT THE PICC WAS REPLACED WITH A SINGLE LUMEN PICC AND THE PATIENT STATUS IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DUAL LUMEN INSERTION TRAY | PICC | LJS | COVIDIEN | 43311 | 23834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |