FDA Adverse Event
Malfunction
Summary report: N
MAXID 19/38 KIT W/OUT SIDEHOL
MDR report key: 2040027
·
Received March 25, 2011
Report
- Report Number
- 1317749-2011-00107
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 14, 2011
- Report Date
- March 14, 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 AFTER USAGE OF 1 MONTH, THERE IS REPORTED TO BE CRACK AT THE TIP OF CATHETER. PHYSICIAN NEEDED TO REINTUBATE A NEW CATHETER FOR PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXID 19/38 KIT W/OUT SIDEHOL | HEMODIALYSIS CATHETER | MSD | COVIDIEN | 8888145001 | 002251 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |