BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE

    MDR report key: 7114987 · Received December 13, 2017

    Report

    Report Number
    9617032-2017-00655
    Event Type
    Malfunction
    Date Received
    December 13, 2017
    Date of Event
    January 31, 2017
    Report Date
    December 11, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY (BD)
    Product Code
    JKA
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: NO SAMPLES WERE RETURNED BY THE CUSTOMER, AND NO PHOTOS WERE ATTACHED. 10 RETAINED NEEDLES FROM THE SAME LOT NUMBER WERE, THEREFORE, TAKEN AT RANDOM, AND EACH USED (IN CONJUNCTION WITH BD SUHS) TO DRAW 5 VACUTAINERS WITH HORSE BLOOD. THE BLOOD WAS IN AN ELEVATED RESERVOIR TO SIMULATE VENOUS PRESSURE. NO LEAKAGES OCCURRED FROM ANY OF THE NEEDLES DURING THIS EXERCISE. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5180354. CONCLUSION: WITHOUT A SAMPLE, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE HAD LEAKAGE OF BLOOD AT THE VIEWING CHAMBER. NO BLOOD EXPOSURE TO MUCOUS MEMBRANE. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891902 BD VACUTAINER® ECLIPSE¿ SIGNAL¿ BLOOD COLLECTION NEEDLE BLOOD COLLECTION DEVICE JKA BECTON, DICKINSON AND COMPANY (BD) 5180354

    Patients

    Seq Age Sex Outcome Treatment
    1 Other