FDA Adverse Event Injury Summary report: N

HEPARIN

MDR report key: 1055508 · Received June 2, 2008

Report

Report Number
MW5007112
Event Type
Injury
Date Received
June 2, 2008
Date of Event
January 1, 2008
Report Date
June 2, 2008
Manufacturer
TYCO HEALTHCARE (NOW COVIDIEN)
Product Code
NZW
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
NC, US
Reporter Occupation
PATIENT FAMILY MEMBER OR FRIEND

Narratives

Description of Event or Problem · 1

MY MOTHER KEEPS GETTING INFECTIONS, SO FAR THIS YEAR SHE HAS HAD 3 OR 4 URINARY TRACT INFECTIONS, AND SHE KEEPS ENDING UP IN THE HOSPITAL WITH INFECTIONS AND I COULDN'T PUT TOGETHER WHAT WAS GOING ON, UNTIL HER HOME HEALTH NURSE CAME TODAY AND TOLD HER SHE HAD ANOTHER URINARY TRACT INFECTION, SO I BEGAN RESEARCHING THE HEPARIN RECALL. SHE TAKES HEPARIN EVERYDAY BECAUSE SHE'S ON TPN THERAPY. SO I LOOKED AT THE RECALLS AND HER HEPARIN IS SUPPLIED TO HER BY ADVANCED HOME HEALTH CARE, WHICH USES HEPARIN MADE BY, OR DISTRIBUTED BY COVIDIEN FORMALLY TYCO HEALTHCARE GROUP. THEY RECALLED SEVERAL LOTS OF HEPARIN, THEY ARE LOT NUMBERS 8010194 - 3ML. FILL, 7072154 - 3ML FILL AND 7041194 - HEPARIN HAS BEEN LINKED WITH THE BACTERIA SERRATIA MARCESCENS. WHICH IS MOST COMMONLY ASSOCIATED WITH CATHETER USE - INTRAVENOUS, INTRAPERITONEAL AND URINARY. HER HEALTH HAS DECLINED ESPECIALLY THIS YEAR WITH SO MANY INFECTIONS SHE IS GETTING, AND I SUSPECT THAT IT IS COMING FROM CONTAMINATED HEPARIN WHICH I STATED ABOVE SHE TAKES EVERYDAY, AND HAS TAKEN IT EVERYDAY THIS YEAR. DATES OF USE: 2006 - 2008. DIAGNOSIS OR REASON FOR USE: TPN THERAPY, TO KEEP HER PIC-LINE OPEN.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 HEPARIN NONE NZW TYCO HEALTHCARE (NOW COVIDIEN) 8010194
2 HEPARIN NONE NZW TYCO HEALTHCARE (NOW COVIDIEN) 7072154

Patients

Seq Age Sex Outcome Treatment
1 62 YR Hospitalization| O