FDA Adverse Event
Malfunction
Summary report: N
PALINDROME EMERALD 23/40 KIT
MDR report key: 2742281
·
Received September 5, 2012
Report
- Report Number
- 1317749-2012-00192
- Event Type
- Malfunction
- Date Received
- September 5, 2012
- Date of Event
- August 20, 2012
- Report Date
- August 20, 2012
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) 2012. 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) 2012 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER. THE CUSTOMER STATES THE CATHETER LEAKED FROM THE HUB. THE HEAD NURSE DISCOVERED THE LEAKAGE WHEN SHE WAS FLUSHING THE CATHETER BEFORE STARTING UP THE DIALYSIS TREATMENT. THERE WAS NO HARM TO THE PATIENT BUT DUE TO LOGISTICS, THE PATIENT CANNOT HAVE THE CATHETER REPLACED AT THIS TIME. AS A RESULT, THE ANESTHESIOLOGIST REMOVED THE CATHETER AND REPLACED IT WITH A CENTRAL VENOUS CATHETER (CVK).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PALINDROME EMERALD 23/40 KIT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145044C | 104997 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |