BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT

    MDR report key: 1064500 · Received June 24, 2008

    Report

    Report Number
    1119779-2008-00008
    Event Type
    Injury
    Date Received
    June 24, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 23, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETURN MATERIAL FROM THE CUSTOMER WAS UNAVAILABLE FOR INVESTIGATION. THE CUSTOMER COULD NOT PROVIDE A LOT NUMBER; THEREFORE, RETENTION MATERIAL COULD NOT BE EXAMINED. A REVIEW OF THE COMPLAINT SYSTEM WAS CONDUCTED AND SHOW NON OTHER REPORT OF THIS DEFECT ON THIS PRODUCT CATALOG NUMBER. ALTHOUGH THE CUSTOMER INDICATED THAT THE CAPS WERE NOT TOO TIGHT, INVESTIGATION BY PRODUCT FAMILY NOTED THAT THE CAP USED ON THIS TUBE TYPE WAS IDENTIFIED AS A CONTRIBUTING FACTOR LEADING TO OCCURRENCES WHERE SOME CAPS REQUIRED HIGHER THAN USUAL REMOVAL FORCE. FOR THIS CATALOG NUMBER, TUBES MADE AFTER 2008 HAVE UTILIZED A NEW CAP SHELL. THESE TUBES SHOW IMPROVEMENT IN THE AMOUNT OF FORCE REQUIRED TO REMOVE THE CAP FROM THE TUBE. BD WILL CONTINUE TO MONITOR THIS PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT AN EMPLOYEE WAS OPENING A TUBE AND THE TUBE SHATTERED IN THE PERSON'S HAND. THE EMPLOYEE WAS CUT AND REQUIRED THREE STITCHES. THE CUSTOMER WAS UNABLE TO PROVIDE A LOT NUMBER AND SAID THAT HE DID NOT HAVE ANY MORE OF THE TUBES LEFT. THE CUSTOMER REMARKED THAT THIS WAS A SINGLE ISOLATED INCIDENT, AND HE DID NOT THINK THAT THE TUBE WAS TIGHTLY CAPPED SINCE THE REST OF THE LOT DID NOT HAVE TIGHT CAPS. THE CUSTOMER SAID THAT THE EMPLOYEE IS OK AND HAS RETURNED TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT JSG BD DIAGNOSTICS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other