BEUDAMED
    FDA Adverse Event Other Summary report: N

    BBL THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR

    MDR report key: 1017141 · Received March 20, 2008

    Report

    Report Number
    1119779-2008-00005
    Event Type
    Other
    Date Received
    March 20, 2008
    Date of Event
    February 25, 2008
    Report Date
    March 21, 2008
    Manufacturer
    BD DIAGNOSTICS
    Product Code
    JSG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE 97 TUBES FROM THIS LOT WERE RETURNED FROM THE CUSTOMER FOR INVESTIGATION. FIVE TUBES WERE OPENED EASILY BY HAND. TEN RANDOM TUBES WERE TESTED FOR TORQUE WITH READINGS FROM 3.4 TO 7.9 IN/LB. TWO OF THE TEN TUBES TESTED FOR TORQUE WERE UNABLE TO BE OPENED. AN ADDITIONAL 25 TUBES WERE TESTED FOR TORQUE AND SIX WERE HIGHER THAN 8 IN/LB. THE REMAINING 19 WERE WITHIN THE SATISFACTORY RANGE OF 3.0-8.0 IN/LB. ADDITIONALLY, THESE 25 TUBES WERE MEASURED FOR CRITICAL DIMENSIONS AND FOUND TO BE WITHIN SPECIFICATION. RETENTION SAMPLES WERE TESTED FOR EASE TO OPEN AND TORQUE. THREE TUBES WERE EASY TO OPEN AND TWO TUBES WERE VERY HARD TO OPEN. THE TORQUE TESTING RESULTS WERE BETWEEN 5.2 TO 8.0 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 SYSTEM WAS CONDUCTED AND SHOW NO OTHER REPORTED OF THIS DEFECT ON THIS PRODUCT 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 CAPS ON THE MEDIA WERE TOO TIGHT. AN EMPLOYEE BROKE THE GLASS TUBE IN HER HAND WHILE ATTEMPTING TO OPEN IT. THE EMPLOYEE'S FINGER WAS CUT AND REQUIRED STITCHES. THE EMPLOYEE ALSO RECEIVED A TETANUS SHOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BBL THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR JSG BD DIAGNOSTICS 7302935

    Patients

    Seq Age Sex Outcome Treatment
    1 Other