BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 7059589 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00582
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 22, 2016
    Report Date
    October 26, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686501
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 5303788, MEDICAL DEVICE EXPIRATION DATE: 10/31/2018, DEVICE MANUFACTURE DATE: 10/30/2015. MEDICAL DEVICE LOT #: 5303789, MEDICAL DEVICE EXPIRATION DATE: 10/31/2018, DEVICE MANUFACTURE DATE: 10/30/2015. MEDICAL DEVICE LOT #: 5903790, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. RESULTS: RECEIVED 100 SAMPLES OF LOT # 5303788 AND 5303789. TESTED 20 SAMPLES OF LOT # 5303788 AND 5303789. ONE SAMPLE FROM LOT # 5303788 HAS DEFECT. NONE OF THE SAMPLES FROM LOT # 5303789 HAD DEFECTS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOTS # 5303788 AND 5303789. UNABLE TO PERFORM DEVICE HISTORY RECORD REVIEW FOR LOT # 5903790. CONCLUSION: ROOT CAUSE WAS INDETERMINATE BASED ON THE INVESTIGATION RESULTS. NO ROOT CAUSE WAS IDENTIFIED FROM THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLOOD DRIPPING FROM PLUNGER OF 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER INTO VACUTAINER GUARD CAUSING BLOOD TO SPILL. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841231 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER BLOOD COLLECTION NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10 50382903686501

    Patients

    Seq Age Sex Outcome Treatment
    1 Other