BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHIO MEDICAL

    MDR report key: 3739002 · Received March 4, 2014

    Report

    Report Number
    2133713-2014-00007
    Event Type
    Malfunction
    Date Received
    March 4, 2014
    Date of Event
    January 20, 2014
    Report Date
    March 3, 2014
    Manufacturer
    BEMIS MFG. CO.
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    PIECES OF THE LID THAT WERE RETURNED WERE PHOTOGRAPHED AND SUBJECT TO FTIR ANALYSIS. FTIR INDICATED A HIGH DEGREE OF OXIDATION CONSISTENT WITH UV EMBRITTLEMENT. CANISTER WAS A COMPONENT OF A PORTABLE PUMP, EXPOSED TO LIGHTING FOR AN EXTENDED PERIOD. PRODUCT WAS TWO YEARS PAST ITS EXPIRATION DATE.

    Description of Event or Problem · 1

    BIOMED ENGINEER WAS PERFORMING A "MAX VACUUM" TEST ON A CRASH CART WHEN THE CANISTER LID IMPLODED. THERE WAS NO PT INVOLVEMENT AND NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130804 OHIO MEDICAL BOTTLE, COLLECTION, VACUUM KDQ BEMIS MFG. CO. AI4120000 20090223

    Patients

    Seq Age Sex Outcome Treatment
    1