BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SPECIALTY TUBES BD HEMOGARD¿/CLEAR

    MDR report key: 7098136 · Received December 7, 2017

    Report

    Report Number
    1024879-2017-01036
    Event Type
    Malfunction
    Date Received
    December 7, 2017
    Date of Event
    May 11, 2017
    Report Date
    January 24, 2018
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMH
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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 RECEIVED REPRESENTATIVE SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE ACTUAL DEVICE WAS NOT RETURNED. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPER PULL OUT WITH THE INCIDENT LOT WAS NOT OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT AND NO ISSUES WERE IDENTIFIED. CONCLUSION: 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 MEDICAL DEVICE TYPE. THE CORRECT TYPE IS FMH. THE INITIAL MDR WAS SUBMITTED WITH N/A AS THE 510K BUT THIS DEVICE IS LISTED AS EXEMPT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD VACUTAINER® SPECIALTY TUBES BD HEMOGARD¿/CLEAR. BECAME DISENGAGED FROM THE TUBE WHEN DISCONNECTING THE TRANSFER STRAW FROM THE URINE COLLECTION CUP. NO SERIOUS INJURY, NO MEDICAL INTERVENTIONS. NO MUCOUS MEMBRANE EXPOSURE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877961 BD VACUTAINER® SPECIALTY TUBES BD HEMOGARD¿/CLEAR URINE COLLECTION SET. FMH BECTON, DICKINSON & CO., (BD) 6328897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other