BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC SST TUBE

    MDR report key: 7084899 · Received December 5, 2017

    Report

    Report Number
    1024879-2017-01205
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    February 13, 2016
    Report Date
    November 13, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    K901449
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: (B)(6). PARENT COMPLIANT REFERENCES MULTIPLE LOT NUMBERS: MEDICAL DEVICE LOT # 5111799, MEDICAL DEVICE EXPIRATION DATE: 04/30/2016, DEVICE MANUFACTURE DATE: 04/21/2015. MEDICAL DEVICE LOT # 5133958, MEDICAL DEVICE EXPIRATION DATE: 04/30/2016, DEVICE MANUFACTURE DATE: 05/13/2015. MEDICAL DEVICE LOT # 5261823, MEDICAL DEVICE EXPIRATION DATE: 09/30/2016, DEVICE MANUFACTURE DATE: 09/18/2015. MEDICAL DEVICE LOT # 5261822, MEDICAL DEVICE EXPIRATION DATE: 09/30/2016, DEVICE MANUFACTURE DATE: 09/18/2015. RESULTS: BD RECEIVED 9 SAMPLES FROM LOTS 5133958, 5261823, AND 5261822. SAMPLES WERE EXPIRED, SO THEY WERE NOT EVALUATED. PHOTOS WERE ALSO PROVIDED BY THE CUSTOMER FACILITY FOR INVESTIGATION. THE PHOTOS WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MISLABELLED TUBES WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FOR EVALUATION, AND THE CUSTOMER'S INDICATED FAILURE MODE FOR MISLABELED TUBES WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOT #S 5111799, 5133958, AND 5261823 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: BD WAS ABLE TO CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE. CUSTOMER PHOTOS VERIFY THE MISSING AND DOUBLE UNIT LABELS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER RECEIVED A BD VACUTAINER® PLUS PLASTIC SST TUBE WITHOUT A LABEL, ONE WITH A DOUBLE LABEL AND ONE WITH A VACUUM PROBLEM. NO SERIOUS INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861277 BD VACUTAINER® PLUS PLASTIC SST TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 5261822 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other