FDA Adverse Event
Malfunction
Summary report: N
1.9F ARGYLE SINGLE LUMEN PICC
MDR report key: 1872499
·
Received October 8, 2010
Report
- Report Number
- 1317749-2010-00278
- Event Type
- Malfunction
- Date Received
- October 8, 2010
- Date of Event
- September 24, 2010
- Report Date
- September 27, 2010
- Manufacturer
- COVIDIEN
- Product Code
- LJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- UNKNOWN
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) 2010 THAT A CUSTOMER HAD AN ISSUE WITH A SINGLE LUMEN PICC. THE CUSTOMER REPORTED THE PICC WAS PLACED IN THE ANKLE VEIN OF THE PATIENT AND REMAINED IN PLACE AND FUNCTIONAL FOR 54 DAYS. IT WAS NOTICED AT THIS TIME THAT THE PICC STARTED TO LEAK. THE PICC WAS REMOVED AND ANOTHER PICC PLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1.9F ARGYLE SINGLE LUMEN PICC | PICC | LJS | COVIDIEN | 43303 | 635101 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |