FDA Adverse Event
Malfunction
Summary report: N
36CM PERM CATH KIT X5
MDR report key: 2076380
·
Received April 25, 2011
Report
- Report Number
- 1317749-2011-00142
- Event Type
- Malfunction
- Date Received
- April 25, 2011
- Date of Event
- April 15, 2011
- Report Date
- April 19, 2011
- Manufacturer
- COVIDIEN
- Product Code
- LFJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: 04/25/2011. 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 BLEEDING WAS NOTED IN HEMODIALYSIS, AND A PINHOLE WAS DETECTED IN THE INSPECTION. A NEW SET OF HEMODIALYSIS TUBING WAS REPLACED. SURGERY WAS EXTENDED FOR MORE THAN 30MINS. PRODUCT WAS TESTED PRIOR TO USAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 36CM PERM CATH KIT X5 | HEMODIALYSIS CATHETER | LFJ | COVIDIEN | 8817748001 | 016119 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |