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: 7060040 · Received November 27, 2017

    Report

    Report Number
    1024879-2017-00625
    Event Type
    Malfunction
    Date Received
    November 27, 2017
    Date of Event
    July 18, 2016
    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
    TN, 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: THIRTY CUSTOMER SAMPLES WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED SAMPLES FOUND AN IV NEEDLE PROTRUDING OUT OF THE IV SHIELD OF ONE SAMPLE. NO DEFECTS WERE IDENTIFIED IN THE REMAINING TWENTY-NINE SAMPLES. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT #5202603. CONCLUSION: VISUAL INSPECTION OF THE RETURNED SAMPLES FOUND AN IV NEEDLE PROTRUDING OUT OF THE IV SHIELD OF ONE SAMPLE. MOST LIKELY AN EQUIPMENT JAM DURING NEEDLE ASSEMBLY. ISOLATED EVENT.

    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 THE NEEDLE STICKING THROUGH THE PLASTIC COVERING WHILE STILL IN THE BOX. NO INJURY OR MEDICAL INTERVENTION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838838 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 5202603 50382903686075

    Patients

    Seq Age Sex Outcome Treatment
    1 Other