BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    400ML INFECTION CONTROL EVACUATOR

    MDR report key: 991490 · Received January 30, 2008

    Report

    Report Number
    1526350-2008-00004
    Event Type
    Malfunction
    Date Received
    January 30, 2008
    Date of Event
    November 15, 2006
    Report Date
    January 28, 2008
    Manufacturer
    ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS
    Product Code
    GCY
    Removal / Correction Number
    1526350-1/17/08-001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NO INFORMATION

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING FILED RETROSPECTIVELY BY ZIMMER OSP. A TOTAL OF 14 MDRS ARE BEING FILED FOR THE ZIMMER HEMOVAC INFECTION CONTROL SYSTEM. IN EACH CASE, THE EVENT REPORTED RELATES TO A DISASSEMBLY OF THE DEVICE AT A DRAINAGE PORT. IN SOME CASES, THIS DISASSEMBLY WAS OBSERVED BY THE END USER PRIOR TO USE, WHILE IN OTHER CASES, A SPILL OF BODILY FLUID OCCURRED. AT THE TIME OF THE ORIGINAL RECEIPT OF THESE REPORTS, THE INFO WAS NOT CONSIDERED MEDWATCH REPORTABLE. THROUGH CONVERSATIONS WITH PERSONNEL AT A DISTRICT OFFICE, ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS HAS DETERMINED THAT A REMOVAL ACTION FOR CERTAIN LOTS OF THESE DEVICES WILL BE IMPLEMENTED AND A REPORT FILED UNDER 21 CFR PART 806. IN CONJUNCTION WITH THIS REPORTABLE REMOVAL ACTION, MEDWATCH REPORTS ARE BEING FILED RETROSPECTIVELY FOR THE FOURTEEN HISTORICAL COMPLAINTS. NO REPORTS OF INJURY HAVE BEEN RECEIVED BY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS FOR SUBJECT DEVICE.

    Description of Event or Problem · 1

    WHEN ACTIVATING FOR SECOND TIME INTO BAG, NOZZLE POPS OFF, SPILLING BLOOD EVERYWHERE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 400ML INFECTION CONTROL EVACUATOR WOUND DRAINAGE DEVICE GCY ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS 60530243

    Patients

    Seq Age Sex Outcome Treatment
    1 NI