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