BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINERR® PLUS PLASTIC URINE C&S PRESERVATIVE TUBE

    MDR report key: 7098996 · Received December 8, 2017

    Report

    Report Number
    1917413-2017-00411
    Event Type
    Malfunction
    Date Received
    December 8, 2017
    Date of Event
    October 10, 2016
    Report Date
    November 22, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    UDI-DI
    00382903649532
    PMA / PMN Number
    K024240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD LIFE SCIENCES - PREANALYTICAL SYSTEMS HAD RECEIVED FIVE (5) PHOTOS AND (B)(4) SAMPLES FROM YOUR FACILITY FOR INVESTIGATION. BASED ON THE EVALUATION OF THE SAMPLES AND PHOTOS, WE OBSERVED THAT THERE WAS A LABELING DISCREPANCY FOR THE SODIUM BORATE ADDITIVE CONCENTRATION. FURTHER INVESTIGATION ACTIVITIES WERE CONDUCTED AND IT WAS DETERMINED THAT THE SODIUM BORATE ADDITIVE CONCENTRATION OF 2.08 MG/ML LISTED ON THE KIT POLY BAG IS INCORRECT. THE CORRECT SODIUM BORATE ADDITIVE CONCENTRATION IS 3.95 MG/ML AS CORRECTLY NOTED IN THE BD VACUTAINER® C&S PRESERVATIVE TUBE PRODUCT INSERT. ADDITIONALLY, THE FORMULATION OF THE SODIUM BORATE ADDITIVE CONCENTRATION HAS REMAINED THE SAME (3.95 MG/ML) SINCE THE PRODUCT WAS LAUNCHED AND THE PRODUCT HAS ALWAYS BEEN MANUFACTURED USING THIS FORMULA. THEREFORE, THE SODIUM BORATE ADDITIVE CONCENTRATION IN THE INCIDENT LOT NUMBER 6210614 IS CORRECTLY FORMULATED TO 3.95 MG/ML. FURTHER INVESTIGATION ACTIVITIES HAVE IDENTIFIED THE ROOT CAUSE AND AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN IMPLEMENTED AND THE LABEL DISCREPANCY HAS BEEN CORRECTED. CONCLUSION: CAPA (B)(4) WAS INITIATED TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THE LABELLING DISCREPANCY AND IMPLEMENT CORRECTIVE ACTIONS IN ORDER TO REDUCE/MITIGATE FURTHER OCCURRENCE OF THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINERR® PLUS PLASTIC URINE C&S PRESERVATIVE TUBE HAD AN ADDITIVE LABELING DISCREPANCY. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879793 BD VACUTAINERR® PLUS PLASTIC URINE C&S PRESERVATIVE TUBE URINE COLLECTION SET JSM BECTON, DICKINSON & CO. 6210614 00382903649532

    Patients

    Seq Age Sex Outcome Treatment
    1 Other