BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIAC CATH PACK

    MDR report key: 511437 · Received February 13, 2004

    Report

    Report Number
    511437
    Event Type
    Malfunction
    Date Received
    February 13, 2004
    Date of Event
    November 1, 2003
    Report Date
    November 1, 2003
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORTER RECEIVED CUSTOM PACKS THAT WERE PACKAGED IN A DIFFERENT MANNER. THE SITE HAD REQUESTED A CHANGE IN THE PACKAGE CONTENT. THE PACKS OR THEIR CONTENTS ARE SENT TO CARDINAL HEALTH, THE DISTRIBUTOR, FROM THE MFR, NAMIC. THERE WAS A "PIGGYBACK" [THIS WAS A DOUBLE PLASTIC BAG WITH THE INNER MOST PLASTIC BAG CONTAINING THE "MANIFOLD" OR SYRINGE WITH MULTIPLE PORTS TO BE USED IN THE STERILE PORTION] PORTION ON THE OUTSIDE OF THE MAIN PACK THAT WAS NOT STERILE. THE ENTIRE PACK HAD BEEN STERILE BEFORE. [THE OUTSIDE OF THE "PIGGYBACK" STATES "NOT STERILE" BUT THE STAFF ASSUMED THIS MEANT ONLY THE OUTSIDE PLASTIC WRAPPER OF THIS DOUBLE WRAPPED ITEM. IT WAS USED IN THIS MANNER UNTIL FINALLY QUESTIONED BY THE SITE AND DETERMINED FROM THE MFR THAT THE CONTENTS WERE UNSTERILE. THE SITE DID NOT INITIATE THE STERILITY ISSUE, ONLY THE PACKAGING ISSUE. THE MFR SENT OUT A LETTER OF APOLOGY ABOUT THE CONTENTS UNSTERILITY AND A RECALL NOTICE WAS SENT TO THE SITE. 198 PACKS WERE USED ON 198 PTS. THE SITE MAILED LETTERS TO ALL PTS INVOLVED IN THE INCIDENT TO CONTACT THE HOSP IF ANY SIGNS OF INFECTION WERE DETECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC CATH PACK OTHER KCT CARDINAL HEALTH MEDICAL PRODUCTS & SERVICES * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *