FDA Adverse Event
Malfunction
Summary report: N
VNUS TUBING KIT X15
MDR report key: 2431576
·
Received January 5, 2012
Report
- Report Number
- 2953189-2012-00004
- Event Type
- Malfunction
- Date Received
- January 5, 2012
- Date of Event
- November 23, 2011
- Report Date
- January 4, 2012
- Manufacturer
- KIMAL PLC
- Product Code
- KRA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
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)(4) 2012 THAT A CUSTOMER HAD AN ISSUE WITH VNUS TUBING KIT X15. THE CUSTOMER STATES DURING A PROCEDURE, THE TUBE BURST AT THE THICKER PART OF THE CONNECTION WHERE IT IS CONNECTED TO THE PUMP. THE TUBE AND NEEDLE WAS REMOVED AND A NEW TUBE AND NEEDLE USED TO CONTINUE THE SURGERY. THE TUBING DID LEAK ONTO THE SURGICAL FLOOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VNUS TUBING KIT X15 | VNUS TUBING KIT X15 | KRA | KIMAL PLC | 10100/30409 | 11C0183 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |