BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL ASEPTIC TRANSFER KIT HOUSING

    MDR report key: 3202186 · Received June 28, 2013

    Report

    Report Number
    8031000-2013-00106
    Event Type
    Malfunction
    Date Received
    June 28, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    Manufacturer
    ZIMMER SURGICAL S.A
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER AT THE TIME OF THIS REPORT. A FOLLOW UP MEDWATCH WILL BE SUBMITTED ONCE THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TWO UNIVERSAL ASEPTIC TRANSFER KIT HOUSINGS FELL OPEN DURING SURGERY. THERE WAS NO REPORT OF SURGICAL DELAY OR PATIENT INJURY ASSOCIATED WITH THE EVENT. NO ADDITIONAL CLINICAL INFORMATION WAS RECEIVED PRIOR TO THIS REPORT. THIS IS THE FIRST OF TWO MDRS BEING SUBMITTING TO REPORT ONE INCIDENT. REFER TO MDR 8031000-2013-00107 FOR THE SECOND INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295919 UNIVERSAL ASEPTIC TRANSFER KIT HOUSING UNIVERSAL ASEPTIC TRANSFER KIT HOUSING GCJ ZIMMER SURGICAL S.A NA 55843

    Patients

    Seq Age Sex Outcome Treatment
    1