FDA Adverse Event
Malfunction
Summary report: N
PALINDROME 23/40 KIT W/SLOT
MDR report key: 3970237
·
Received April 29, 2014
Report
- Report Number
- 1317749-2014-00205
- Event Type
- Malfunction
- Date Received
- April 29, 2014
- Date of Event
- April 1, 2014
- Report Date
- April 4, 2014
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2014. 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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THAT THE SEALING CAP HAS A TEAR -AIR IN GOING IN. THE ISSUE WAS NOTICED DURING PT USAGE AND THE CATHETER WAS PULLED AND REPLACED WITH A NEW CATHETER. NO FURTHER MEDICAL INTERVENTION WAS NECESSARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256337 | PALINDROME 23/40 KIT W/SLOT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145015 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |