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: 6574185 · Received May 17, 2017

    Report

    Report Number
    1024879-2017-00076
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    April 24, 2017
    Report Date
    July 7, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    RESULTS: TWO SAMPLES IN OPEN PACKAGES WERE RETURNED FOR EVALUATION. A VISUAL INSPECTION REVEALED THAT SAMPLE ONE WAS RECEIVED WITH COLLAR HUB SEPARATION. SAMPLE TWO WAS RECEIVED WITH THE GREEN IV SHIELD MISSING AND THE SAFETY SHIELD ENGAGED OVER THE IV NEEDLE. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH 6161555. A QN WAS ISSUED FOR HUB/COLLAR SEPARATION. THE QUALITY CONTROL PLAN WAS FOLLOWED. CONCLUSION: AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED AS A MANUFACTURING RELATED ISSUE BECAUSE OF IN-LINE VISION SYSTEMS. HOWEVER, CAPA (B)(4) HAS BEEN OPENED TO INVESTIGATE HUB COLLAR SEPARATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF A 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER BROKE OFF DURING ACTIVATION. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355596 21 G X 1.25 IN. BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6161555

    Patients

    Seq Age Sex Outcome Treatment
    1 Other