FDA Adverse Event
Malfunction
Summary report: N
MAXID 19/38 KIT W/OUT SIDEHOL
MDR report key: 2231088
·
Received July 20, 2011
Report
- Report Number
- 1317749-2011-00216
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- July 4, 2011
- Report Date
- July 4, 2011
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- 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) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER STATES BUBBLES AND FRACTURES WERE SEEN IN THE CATHETER DURING USE WHICH LED TO EXUDATION OF BLOOD AND AFFECTED THE ADEQUACY OF HEMODIALYSIS. THE HOSPITAL REMOVED AND REPLACED THE CATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXID 19/38 KIT W/OUT SIDEHOL | HEMODIALYSIS CATHETER | MSD | COVIDIEN | 8888145001 | 007142 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |