FDA Adverse Event
Malfunction
Summary report: N
PALIND 23/40 SLOT SPRT W/VT
MDR report key: 2980247
·
Received February 1, 2013
Report
- Report Number
- 1317749-2013-00063
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 15, 2013
- Report Date
- January 21, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER REPORTS THERE WAS AIR IN THE TUBING, DRESSING VERIFIED AND A SUCTION SOUND COMING FROM THE CATHETER. BLOOD WAS LEAKING FROM UNDER THE CATHETER, THERE IS A .5 CM OPENING WHERE THE CATHETER SHAFT BEGINS. THE CATHETER WAS PLACE ON (B)(6) 2012 AND REPLACED ON (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45398 | PALIND 23/40 SLOT SPRT W/VT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888123404 | 202013X |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |