BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE

    MDR report key: 6586337 · Received May 23, 2017

    Report

    Report Number
    1024879-2017-00070
    Event Type
    Malfunction
    Date Received
    May 23, 2017
    Date of Event
    May 4, 2017
    Report Date
    July 3, 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
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THERE IS NO 510(K) FOR THIS DEVICE AS IT IS NOT MARKETED IN THE US. 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: SIX UNUSED SAMPLES WERE RECEIVED FOR EVALUATION. EACH SAMPLE WAS HAND ACTIVATED TO EVALUATE THE SAFETY SHIELD FALLING OFF. THE SAFETY SHIELD WAS ROTATED BACKWARD WITH EASE WITH NO IV SHIELD LIFT IDENTIFIED. THE SAFETY SHIELD WAS THEN ENGAGED OVER THE IV NEEDLE. THE LOCK-OUT FEATURES ENGAGED APPROPRIATELY AND NO BREAKAGE, FULL OR PARTIAL DISENGAGEMENT OF THE SAFETY SHIELD FROM THE BODY OF THE UNIT WAS IDENTIFIED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT # 7041545. CONCLUSION: 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SAFETY SHIELD OF A 21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE BROKE OFF AFTER THE SAFETY ACTIVATION WAS PERFORMED ON A BED. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364853 21 G X 1.25 IN. BD VACUTAINER® ECLIPSE¿ BLOOD COLLECTION NEEDLE SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) 7041545

    Patients

    Seq Age Sex Outcome Treatment
    1 Other