BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 7085800 · Received December 5, 2017

    Report

    Report Number
    1024879-2017-00688
    Event Type
    Malfunction
    Date Received
    December 5, 2017
    Date of Event
    December 6, 2016
    Report Date
    November 27, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS REFERENCED IN THE PARENT COMPLAINT. MEDICAL DEVICE LOT # 6231990, MEDICAL DEVICE EXPIRATION DATE: 08/31/2021, DEVICE MANUFACTURE DATE: 08/18/2016. MEDICAL DEVICE LOT # 6224667, MEDICAL DEVICE EXPIRATION DATE: 08/31/2021, DEVICE MANUFACTURE DATE: 08/11/2016. MEDICAL DEVICE LOT # 6106694, MEDICAL DEVICE EXPIRATION DATE: 04/30/2021, DEVICE MANUFACTURE DATE: 04/15/2016. (B)(6). RESULTS: BD RECEIVED SAMPLES AND PHOTOS FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES AND PHOTOS WERE EVALUATED AND THE CUSTOMER¿S INDICATED FAILURE MODE FOR SEPARATION WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR THE INCIDENT LOTS AND NO ISSUES WERE IDENTIFIED. CONCLUSION: THE ROOT CAUSE / POTENTIAL ROOT CAUSE FOR THE HUB/COLLAR SEPARATION WAS DETERMINED TO BE EXCESS TORQUE APPLIED TO THE ECLIPSE UNITS WHEN SCREWING INTO THE HOLDERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GREEN NEEDLE SAFETY SHIELD OF BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE DETACHED AFTER ATTACHING THE NEEDLE TO THE HOLDER. NO INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863560 BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAFETY ENGINEERED SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1 Other