BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE

    MDR report key: 6749296 · Received July 27, 2017

    Report

    Report Number
    1917413-2017-00095
    Event Type
    Malfunction
    Date Received
    July 27, 2017
    Date of Event
    February 22, 2017
    Report Date
    July 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO.
    Product Code
    JKA
    PMA / PMN Number
    K981013
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THREE LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6313681, MEDICAL DEVICE EXPIRATION DATE: 3/31/2018, DEVICE MANUFACTURE DATE: 11/8/2016; MEDICAL DEVICE LOT #: 6253710, MEDICAL DEVICE EXPIRATION DATE: 1/31/2018, DEVICE MANUFACTURE DATE: 9/9/2016; MEDICAL DEVICE LOT #: 6253705, MEDICAL DEVICE EXPIRATION DATE: 1/31/2018, DEVICE MANUFACTURE DATE: 9/9/2016. RESULTS: (B)(4) SAMPLES OF LOT 6313681 AND (B)(4) SAMPLES OF LOT 6253705 WERE RETURNED FOR EVALUATION. NO SAMPLES OF LOT 6253710 WERE RETURNED. (B)(6) CUSTOMER SAMPLES AND (B)(4) CONTROL SAMPLES WERE TESTED FOR DRAW ACCORDING TO VS50007. ALL TUBES TESTED WITHIN SPECIFICATION. THE TUBES WERE VISUALLY INSPECTED FOR CREEP OUT. THERE WERE NO TUBES THAT DEMONSTRATED CREEP OUT. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO RELATED QUALITY NOTIFICATIONS. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS OF 13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBES DO NOT SNAP BACK AND AFTER A FEW MINUTES SLIPS OFF THE TUBES. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529564 13X75 MM 4.0 ML BD VACUTAINER® PLUS PLASTIC WHOLE BLOOD TUBE BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO. SEE SECTION H.10.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other