BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE¿ NEEDLE FOR LUER LOCK SYRINGES

    MDR report key: 6998094 · Received November 2, 2017

    Report

    Report Number
    8041187-2017-00149
    Event Type
    Malfunction
    Date Received
    November 2, 2017
    Date of Event
    October 9, 2017
    Report Date
    November 17, 2017
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    UDI-DI
    30382903057611
    PMA / PMN Number
    K161170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: NO ACTUAL SAMPLES WERE RECEIVED FOR EVALUATION. FIVE SAMPLES FROM BATCH 6140348 WERE RETURNED FOR INVESTIGATION. REPRESENTATIVE SAMPLES WERE SUBJECTED TO VISUAL INSPECTION. NO DEFECT WAS OBSERVED ON THE REPRESENTATIVE SAMPLES. REPRESENTATIVE SAMPLES MET THE PRODUCT SPECIFICATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6140348 . BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NEEDLE ON A 25 G X 1 IN. BD ECLIPSE¿ NEEDLE FELL OFF AFTER LOCKING THE COVER OVER THE NEEDLE POST USE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    775027 BD ECLIPSE¿ NEEDLE FOR LUER LOCK SYRINGES HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 6140348 30382903057611

    Patients

    Seq Age Sex Outcome Treatment
    1 Other