FDA Adverse Event
Malfunction
Summary report: N
PALINDROME HSI KIT 23/40 CM X5.
MDR report key: 3071155
·
Received April 8, 2013
Report
- Report Number
- 1317749-2013-00122
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- March 12, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 REPORTS THE CATHETER SLIPPED OUT OF THE PATIENT REVEALING THE CUFF AND SILVER ION SLEEVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 144526 | PALINDROME HSI KIT 23/40 CM X5. | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145048C | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |