BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OHIO MEDICAL COLLECTION BOTTLE

    MDR report key: 6867466 · Received September 14, 2017

    Report

    Report Number
    1419185-2017-00002
    Event Type
    Malfunction
    Date Received
    September 14, 2017
    Date of Event
    August 4, 2017
    Report Date
    September 14, 2017
    Manufacturer
    OHIO MEDICAL LLC
    Product Code
    KDQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IMMEDIATELY UPON NOTIFICATION ON (B)(4) 2017, THE PRODUCT REFERENCED, PN 6700-0209-500, WAS PLACED IN QUARANTINE DURING FAILURE INVESTIGATION. ENGINEERING AND QUALITY ASSURANCE COMPLETED A FAILURE INVESTIGATION SUMMARIZED BELOW: · COMPLAINT HISTORY WAS ANALYZED FROM 2010 TO CURRENT DATE AND A TOTAL OF 3 COMPLAINTS RESULTED IN 26 SIMILAR BOTTLE FAILURES (20 OF THE 26 BOTTLES WERE RECEIVED FROM SAME DISTRIBUTOR IN (B)(4) WHO INITIATED THIS COMPLAINT) AND 10 BOTTLE FAILURES WERE REPORTED DUE TO CRACKS. · PRODUCT SPECIFICATIONS, SPECIFICALLY WALL THICKNESS AND MATERIAL USED, IS VERIFIED UPON EACH RECEIPT OF COLLECTION BOTTLES FROM OUR SUPPLIER. INCOMING INSPECTION RECORDS WERE REVIEWED FROM 2013 TO CURRENT DATE AND NO ANOMALIES WERE NOTED. · CLEANING METHOD USED BY THIS CUSTOMER WAS CONFIRMED TO BE ACCEPTABLE PER DEVICE IFU. · ENGINEERING TESTING WAS PERFORMED ON THE SAME LOT NUMBERS. THE BOTTLES UNDERWENT DIFFERENT FILL AND VACUUM LEVEL SCENARIOS AND IT WAS DETERMINED THAT THE DEVICE PERFORMED TO MANUFACTURERS SPECIFICATIONS. UPON REVIEW OF RETROSPECTIVE COMPLAINT DATA, INCOMING INSPECTION AND DISPOSITION REPORTS, AND ALL RELATED PRODUCTION RECORDS IT WAS DETERMINED THAT APPROXIMATELY 1% OF ALL BOTTLES DISTRIBUTED IN (B)(6) EXPERIENCED IMPLOSION FAILURES. THE PRODUCT WAS NOT RETURNED FROM THE CUSTOMER FOR EVALUATION. THE MALFUNCTION COULD NOT BE DUPLICATED AT THE MANUFACTURER, HOWEVER, OHIO MEDICAL IS CONTINUING EVALUATION OF (B)(6) ENVIRONMENTAL VACUUM LEVELS IN RELATION TO THE IFU SPECIFYING "0 TO FULL VACUUM" FOR OPPORTUNITY TO REVISE INSTRUCTIONS FOR USE FOR THIS REGION.

    Description of Event or Problem · 1

    ON (B)(6) 2017 A FIELD REPRESENTATIVE IN (B)(6) COMMUNICATED A COMPLAINT TO OHIO MEDICAL VIA EMAIL SUMMARIZED BELOW: A COLLECTION BOTTLE FAILED DUE TO IMPLOSION DURING A PROCEDURE IN (B)(6). THE CUSTOMER NAME OR PRODUCT IDENTIFICATION WAS NOT INITIALLY INCLUDED. THE FIELD REPRESENTATIVE WAS ASKED TO GET ADDITIONAL INFORMATION TO SUPPORT FAILURE INVESTIGATION. A COMPLAINT FORM WAS SENT TO THE FIELD AND FILLED OUT BY THE DISTRIBUTOR AND FORWARDED TO OHIO MEDICAL FROM OUR FIELD REPRESENTATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645914 OHIO MEDICAL COLLECTION BOTTLE COLLECTION BOTTLE KDQ OHIO MEDICAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1