FDA Adverse Event
Injury
Summary report: N
COVIDIEN/KENDALL
MDR report key: 1376076
·
Received May 5, 2009
Report
- Report Number
- MW5010994
- Event Type
- Injury
- Date Received
- May 5, 2009
- Date of Event
- April 7, 2009
- Report Date
- May 5, 2009
- Manufacturer
- 15 HAMPSHIRE STREET
- Product Code
- MPB
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Description of Event or Problem · 1
A PALINDROME DIALYSIS CATHETER BY COVIDIEN/KENDALL - VASCULAR THERAPY DIVISION- WAS PLACED IN A PT. THE END OF THE CATHETER-LUERLOCK PORTION-CRACKED AND NEEDED AN EXCHANGE. THIS REQUIRED THE PT CO COME IN FOR AN INVASIVE PROCEDURE TO CONTINUE WITH DIALYSIS. DATES OF USE: 2009. DIAGNOSIS -ESRD-.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COVIDIEN/KENDALL | PALINDROME SPORT PACK DIALYSIS CATHETER | MPB | 15 HAMPSHIRE STREET | 8888119364 | 806738 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Disability |