BEUDAMED
    FDA Adverse Event Other Summary report: N

    LINER CANNSTR SUCT 3000CC DISP

    MDR report key: 927850 · Received October 15, 2007

    Report

    Report Number
    1423507-2007-00109
    Event Type
    Other
    Date Received
    October 15, 2007
    Date of Event
    September 27, 2007
    Report Date
    October 15, 2007
    Manufacturer
    CARDINAL HEALTH
    Product Code
    KDQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ASSEMBLY RETURNED FOR INVESTIGATION EXHIBITED SEVERE DAMAGE INDICATIVE OF AN IMPLOSION EVENT WHERE THE LID WAS TOTALLY SEPARATED INTO MULTIPLE PIECES. THE LID REMNANT HELPED IDENTIFY THE LID CAVITY NUMBER AS "6". THE LID DATE CODE WAS 8-07 (AUGUST 2007), WHICH REPRESENTS THE DATE OF MANUFACTURE OF THE LID. IT WOULD BE EXPECTED THAT THE ASSEMBLY AND PACK OUT TIME FRAME WOULD ALSO BE WITHIN THIS GENERAL PERIOD. THE RETURNED UNIT WAS DIMENSIONALLY INSPECTED. THE LID COMPONENT MET THE SPECIFICATION REQUIREMENT FOR WALL THICKNESS. THE PRODUCT IS DESIGNED TO MEET IMPLOSION RESISTANCE REQUIREMENTS PER ISO 10079-3 "MEDICAL SUCTION EQUIPMENT- PART 3: SUCTION EQUIPMENT POWERED FROM VACUUM OR PRESSURE SOURCE. UNFORTUNATELY, NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER; THEREFORE, AN INVESTIGATION OF THE MANUFACTURING DEVICE HISTORY RECORD COULD NOT BE PERFORMED. DISCUSSIONS WERE HELD WITH KEY QUALITY, MARKETING AND TECHNICAL PERSONNEL REGARDING THIS CONCERN, WHILE NO DEFINITIVE ROOT CAUSE COULD BE IDENTIFIED BY THE COMPLAINT INVESTIGATION, SUCH AN EVENT MAY OCCUR IF THE UNIT WAS DAMAGED PRIOR TO USE OR, IF THE PRODUCT WAS SUBJECT TO STATIC VACUUM PRIOR TO USE FOR AN EXTENDED PERIOD.

    Description of Event or Problem · 1

    CANISTER LINER "EXPLODED" PER A CRNA WHO WAS THE ONLY PERSON IN THE OR AT THE TIME . WHEN THE EXPLOSION HAPPENED, THE LID SHATTERED, WENT PROJECTILE, AND LINER SPLIT DOWN THE SIDE. NO ONE WAS HANDLING THE CANISTER AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINER CANNSTR SUCT 3000CC DISP SUCTION CANISTER LINER KDQ CARDINAL HEALTH 65651-530 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA YR