BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® C & S BORIC ACID SODIUM KIT BORATE / FORMED

    MDR report key: 7007736 · Received November 7, 2017

    Report

    Report Number
    1917413-2017-00348
    Event Type
    Malfunction
    Date Received
    November 7, 2017
    Date of Event
    December 14, 2015
    Report Date
    January 22, 2018
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JSM
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #5061853 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE INCORRECT DEVICE TYPE CODE. THE CORRECT DEVICE TYPE CODE IS JSM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INDIVIDUAL PACKAGING OF BD VACUTAINER® C & S BORIC ACID SODIUM KIT BORATE / FORMED WAS BADLY SEALED. STERILE BREACH. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    787838 BD VACUTAINER® C & S BORIC ACID SODIUM KIT BORATE / FORMED URINE COLLECTION TUBE JSM BECTON, DICKINSON & CO. 5061853

    Patients

    Seq Age Sex Outcome Treatment
    1 Other