FDA Adverse Event
Malfunction
Summary report: N
PALIDROME 28/45 KIT W/ SLOT
MDR report key: 3222137
·
Received July 2, 2013
Report
- Report Number
- 1317749-2013-00210
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Date of Event
- May 31, 2013
- Report Date
- June 7, 2013
- Manufacturer
- COVIDIEN
- Product Code
- MSD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
SUBMIT DATE: (B)(4) 2013. 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 STATES THAT ONCE THE TREATMENT WAS COMPLETED, SHE THEN WENT TO CLOSE THE CATHETER WITH A SODIUM CITRATE 4% CAP. SHE OBSERVED THAT THE RED ADAPTER WAS TURNING IN THE EXTENSION TUBE, BUT WITHOUT ANY LEAKAGE. THERE WAS NOT PT INJURY OR ILL EFFECT. THE CATHETER WAS PULLED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300962 | PALIDROME 28/45 KIT W/ SLOT | DIALYSIS CATHETER | MSD | COVIDIEN | 8888145016 | 006432 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |