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: 6298344 · Received February 2, 2017

    Report

    Report Number
    1024879-2017-00009
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    January 17, 2017
    Report Date
    March 13, 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
    AR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION, HOWEVER THE CUSTOMER PROVIDED THREE PHOTOS OF THE AFFECTED DEVICE. A PHOTO INSPECTION SHOWED AN ECLIPSE UNIT WITH THE COLLAR DETACHED FROM THE HUB. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 6203554. CONCLUSION: ALTHOUGH THE PHOTOS CONFIRMED THE REPORTED DEFECT, 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. REMEDIAL ACTION REQUIRED: CAPA (B)(4) HAS BEEN INITIATED TO DOCUMENT THE INVESTIGATION PATH, ROOT CAUSE ANALYSIS AND REMEDIATION PLAN, INCLUDE CORRECTIVE AND PREVENTIVE ACTIONS FOR THE REPORTED DEFECT, HUB COLLAR SEPARATION.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY MECHANISM OF A 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER FELL OFF OF THE NEEDLE WHEN IT WAS ATTACHED TO A HOLDER. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78410 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6203554

    Patients

    Seq Age Sex Outcome Treatment
    1 Other