BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® WINGED SAFETY PBBCS WITH 7 IN TUBING AND LUER ADAPTER

    MDR report key: 7060203 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00191
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    October 20, 2015
    Report Date
    October 20, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903673360
    PMA / PMN Number
    K030573
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). RESULTS: A SAMPLE WAS RETURNED FOR EVALUATION THAT SHOWED THE CUSTOMERS DEFECT. VISUAL INSPECTION OF THE PHOTOS CONFIRMED FOREIGN MATTER ON OR EMBEDDED IN THE PRODUCT. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 4111634. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RED FOREIGN MATTER ON THE 23 G X .75 IN BD VACUTAINER® WINGED SAFETY PBBCS WITH 7 IN TUBING AND LUER ADAPTER. THE INITIAL REPORTER ASKED THAT THEY BE REMOVED AND REPLACED. NO PATIENT CONTACT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    840808 BD VACUTAINER® WINGED SAFETY PBBCS WITH 7 IN TUBING AND LUER ADAPTER WINGSET JKA BECTON, DICKINSON & CO., (BD) 4111634 00382903673360

    Patients

    Seq Age Sex Outcome Treatment
    1 Other