FDA Adverse Event
Malfunction
Summary report: N
MAHURKAR MAXID 23 CM
MDR report key: 2040018
·
Received March 25, 2011
Report
- Report Number
- 1317749-2011-00112
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Report Date
- March 18, 2011
- Manufacturer
- COVIDIEN
- Product Code
- FJS
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, 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 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS THE MAHURKAR MAXID CATHETER 23 CM DEVELOPED A HOLE, UNDER THE CLAMPS. CATHETER HAS BEEN IN PLACE LESS THAN 6 WEEKS. THE CATHETER HAD TO BE REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAHURKAR MAXID 23 CM | HEMODIALYSIS CATHETER | FJS | COVIDIEN | UNKNOWN DY | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |