FDA Adverse Event
Malfunction
Summary report: N
PALINDROME SAPPHIRE 23/40KT VT
MDR report key: 3770428
·
Received March 6, 2014
Report
- Report Number
- 1317749-2014-00148
- Event Type
- Malfunction
- Date Received
- March 6, 2014
- Date of Event
- February 17, 2014
- Report Date
- March 4, 2014
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AN INVESTIGATION IS CURRENTLY UNDERWAY, UPON COMPLETION THE RESULTS WILL BE FORWARDED.
Description of Event or Problem · 1
IT WS REPORTED TO COVIDIEN ON (B)(6) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THERE WAS A LEAK AT THE Y JUNCTION. THE CATHETER WAS PLACED IN RIGHT JUGULAR. THE PHYSICIAN APPLIED DERMOBAN (GLUE) INTO THE CATHETER TO MITIGATE LEAKAGE POWER AND PROGRAM THE CATHETER CHANGE. THE GLUE WAS APPLIED ON (B)(6) 2014, THE CATHETER WAS PULLED ON (B)(6) 2014. WHEN THE PHYSICIAN RETIRED THE CATHETER, HE NOTES A BREAK IN THE CATHETER BODY. THE CATHETER REMAINED IN THE PATIENT DURING 4 YEARS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 138053 | PALINDROME SAPPHIRE 23/40KT VT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145048 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |