FDA Adverse Event
Malfunction
Summary report: N
UNK DY
MDR report key: 2030319
·
Received March 21, 2011
Report
- Report Number
- 1317749-2011-00099
- Event Type
- Malfunction
- Date Received
- March 21, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 9, 2011
- Manufacturer
- ARGYLE (SHERIDAN)
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2011. 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE CATHETER LUMEN (EXTENSION) BURST IMMEDIATELY UPON START OF DIALYSIS TREATMENT. THE INSERTING PHYSICIAN STATED THAT HE HAD SOME TROUBLE WITH INSERTION OF THE CATHETER AND BELIEVES THAT THE GUIDEWIRE MAY HAVE DAMAGED THE LUMEN THAT BURST. CATHETER WAS CLAMPED AND IMMEDIATELY REMOVED. A REPLACEMENT CATHETER WAS INSERTED. NO FURTHER INTERVENTION REQUIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK DY | HEMODIALYSIS CATHETER | MPB | ARGYLE (SHERIDAN) | UNK DY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |