FDA Adverse Event
Malfunction
Summary report: N
PALINDROME SAPPHIRE 19/36SP
MDR report key: 3150368
·
Received May 31, 2013
Report
- Report Number
- 1317749-2013-00167
- Event Type
- Malfunction
- Date Received
- May 31, 2013
- Date of Event
- May 3, 2013
- Report Date
- May 3, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
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) 2013 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER HAD A LEAK IN THE SILICONE EXTENSION WHERE THE CLAMP PINCHES THE CATHETER CLOSED. ANOTHER CATHETER WAS OPENED AND IT TOO HAD A HOLE IN THE SAME PLACE. A THIRD CATHETER WAS OPENED AND THIS CATHETER WAS UTILIZED AS THE REPLACEMENT CATHETER. THERE WAS NO ADVERSE EVENT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240486 | PALINDROME SAPPHIRE 19/36SP | DIALYSIS CATHETER | MSD | COVIDIEN | 8888119369 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |