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: 7060008 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00293
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    August 10, 2015
    Report Date
    October 25, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    UDI-DI
    50382903686075
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. RESULTS: THREE CUSTOMER SAMPLES WERE RECEIVED IN THE ORIGINAL ECLIPSE SHELF CARTON WITH THE TOP TORN OFF. VISUAL INSPECTION OF THE RETURNED SAMPLES FOUND A HOLE IN THE SIDE OF THE GREEN IV SHIELD FOR TWO SAMPLES. ONE OF THE TWO SAMPLES WAS MISSING THE NP SHIELD. INSPECTION OF THE THIRD SAMPLE IDENTIFIED NO DEFECTS.. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 5033715. CONCLUSION: THE ROOT CAUSE WAS A SHIELDER JAM DUE TO FALLEN PARTS IN THE RAIL. THE MACHINE WAS CLEARED AND CHECKED FOR ANY ADDITIONAL PARTS IN THE RAIL. ISOLATED INCIDENT AND NOT REPRESENTATIVE OF OVERALL BATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER HAD ONE NEEDLE WITH A DAMAGED GREEN SLEEVE (HUB), AND A 2ND NEEDLE DID NOT HAVE CLEAR NEEDLE COVER OR GREEN SLEEVE. THERE WAS NO INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838818 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5033715 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other