BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR

    MDR report key: 7116836 · Received December 14, 2017

    Report

    Report Number
    1024879-2017-00994
    Event Type
    Malfunction
    Date Received
    December 14, 2017
    Date of Event
    March 24, 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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. 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: BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH AN INACCURATE EVENT DESCRIPTION BECAUSE THE DEVICE BRAND NAME WAS INCORRECT. IT HAS BEEN CORRECTED TO READ: "IT WAS REPORTED THAT THE STOPPERS OF BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR, WERE COMING OFF. NO INJURY OR MEDICAL INTERVENTION REPORTED." THE INITIAL MDR WAS SUBMITTED WITH THE INCORRECT DEVICE BRAND NAME. THE CORRECT BRAND NAME IS BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR. THE INITIAL MDR WAS SUBMITTED WITH A 510K NUMBER BUT THIS DEVICE IS EXEMPT AND DOES NOT HAVE A 510K ASSOCIATED WITH IT.

    Additional Manufacturer Narrative · 1

    THE INITIAL MDR WAS SUBMITTED WITH THE INCORRECT MEDICAL DEVICE TYPE. THE CORRECT TYPE IS FMH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS OF BD VACUTAINER® PLUS BLOOD COLLECTION TUBE WERE COMING OFF. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS OF BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR, WERE COMING OFF. NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    899216 BD VACUTAINER® SPECIALTY TUBES; DISCARD/NO ADDITIVE, HEMOGARD¿/ CLEAR BLOOD COLLECTION TUBE FMH BECTON, DICKINSON & CO., (BD) 6328897

    Patients

    Seq Age Sex Outcome Treatment
    1 Other