BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT

    MDR report key: 1011985 · Received March 11, 2008

    Report

    Report Number
    1119779-2008-00004
    Event Type
    Other
    Date Received
    March 11, 2008
    Date of Event
    February 12, 2008
    Report Date
    March 10, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SEVEN TUBES FROM THIS LOT WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. TWO TUBES WERE OPENED BY HAND; ONE WAS EASY TO PEN AND THE OTHER WAS DIFFICULT. THE REMAINING FIVE TUBES WERE TESTED FOR TORQUE WITH READINGS FROM 4.6 TO 7.6 IN/LB. THE SATISFACTORY RANGE IS 3.0-8.0 IN/LB WITH A TARGET OF 5.5 IN/LB. ADDITIONALLY, THE DIFFICULT TO OPEN TUBES WERE MEASURED FOR CRITICAL DIMENSIONS AND FOUND TO BE WITHIN SPEC. RETENTION SAMPLES WERE TESTED FOR EASE TO OPEN AND TORQUE. TUBES WERE EASILY OPENED BY A LAB TECH AND THE TORQUE TESTING RESULTS WERE BETWEEN 1.3 TO 5.7 IN/LB. THE BATCH HISTORY RECORD WAS EXAMINED AND FOUND TO BE SATISFACTORY WITH ALL TORQUE READINGS BETWEEN 4.5 AND 6.4 IN/LB DURING FILLING. A REVIEW OF THE COMPLAINT SYS WAS CONDUCTED AND SHOW NO OTHER REPORTED OF THIS DEFECT ON THIS PROD LOT. THIS LOT WILL BE MONITORED FOR FUTURE REPORTS OF THIS DEFECT. A CORRECTIVE ACTION HAS BEEN OPENED TO FURTHER ADDRESS THIS ISSUE.

    Description of Event or Problem · 1

    CUSTOMER CALLED TO REPORT THAT ABOUT HALF OF HER BOX OF 100 TUBES WERE TOO TIGHT AND HARD TO GET OPEN. ONE OF HER LAB ASSISTANCE HAD A TUBE BREAK IN HER HANDS UPON TRYING TO OPEN IT AND CUT HER THUMB REQUIRING STITCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL THIOGLYCOLLATE MEDIUM, ENRICHED WITH VIT JSG BD DIAGNOSTICS 7323024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other