BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUICK CONNECT

    MDR report key: 862500 · Received March 6, 2007

    Report

    Report Number
    1527821-2007-00003
    Event Type
    Malfunction
    Date Received
    March 6, 2007
    Date of Event
    February 5, 2007
    Report Date
    March 6, 2007
    Manufacturer
    STERIS CORPORATION
    Product Code
    BZA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN BOTH CASES, THE USER AT THE MEDICAL CENTER DETECTED THE MISSING CENTER INSERT ON ADAPTER #6 PRIOR TO USE IN THE STERIS SYSTEM 1. AT NO TIME WAS A QUICK CONNECT (QC) WITH A BROKEN ADAPTER #6 USED TO REPROCESS ANY MEDICAL DEVICES. TO DATE, NO REPORTED INJURY, ILLNESS, OR INFECTION HAS OCCURRED AND NO OTHER CUSTOMER COMPLAINTS HAVE BEEN REPORTED FOR THIS ADAPTER. BASED UPON A HEALTH HAZARD ANALYSIS COMPLETED FOR THIS ISSUE, AND THE FACT THAT THE TWO QUICK CONNECTS (QFC 1728 AND QFC 1729) ARE USED TO PROCESS SEMI-CRITICAL GI DEVICES WHICH ARE USED IN NON-STERILE CAVITIES WITHIN THE BODY (GI TRACT), IT IS UNLIKELY THAT AN INFECTION-CAUSING EVENT WOULD OCCUR FROM USE OF A DEVICE PROCESSED WITH A SEPARATED QC. ALL PRODUCTS IN INVENTORY HAVE BEEN TESTED AND INSPECTED FOR FUNCTIONAL INTEGRITY, AND A RECALL HAS BEEN INITIATED SINCE THE POSSIBILITY EXISTS THAT A USER MIGHT NOT DETECT THE BROKEN ADAPTER PRIOR TO USE.

    Description of Event or Problem · 1

    REPORTER CONTACTED STERIS CORPORATION IN 2007 TO REPORT THAT ADAPTOR #6 HAD SEPARATED INTO TWO PIECES ON THEIR QFC1728. THIS IS THE COMPLAINT RELATING TO ADAPTER #6 AT THE FACILITY. WHILE INVESTIGATING THE FEBRUARY 5 COMPLAINT, IT WAS DETERMINED THAT THE ADAPTOR HAD SEPARATED AT THE PRESS FIT. STERIS IDENTIFIED ONLY ONE OTHER ADAPTER THAT EXHIBITED SEPARATION AT THE PRESS FIT DURING A FUNCTIONAL TEST OF INVENTORY, AN INCIDENCE RATE AT OR BELOW 5%. PROCESSING DEVICES WITH A SEPARATED ADAPTER # 6 (CENTER INSERT MISSING) COULD RESULT IN REDUCED FLOW AND POTENTIALLY AFFECT STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUICK CONNECT SYSTEM ONE ACCESSORY DEVICE BZA STERIS CORPORATION QFC1728 2876720

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other