BEUDAMED
    FDA Adverse Event Injury Summary report: N

    21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER

    MDR report key: 5728016 · Received June 15, 2016

    Report

    Report Number
    1024879-2016-00026
    Event Type
    Injury
    Date Received
    June 15, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 30, 2016
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    K982541
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: A LOT # FOR THIS INCIDENT WAS PROVIDED ON 6/20/2016 WHEN THE SAMPLES WERE RECEIVED FOR INVESTIGATION. THE INFORMATION FOR THE LOT # IS AS FOLLOWS: MEDICAL DEVICE LOT #: 6083663. MEDICAL DEVICE EXPIRATION DATE: 3/31/2021. MEDICAL DEVICE MANUFACTURE DATE: 3/25/2016. DEVICE EVALUATION: RESULTS: TWO REPRESENTATIVE SAMPLE WERE RETURNED FOR EVALUATION. EACH SAMPLE WAS HAND ACTIVATED TO EVALUATE DEFECTIVE LOCKING OF THE SAFETY SHIELD. 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 LOCKOUT 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 # 6083663. 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.

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER USING A 21 G X 1.25 IN BD ECLIPSE BLOOD COLLECTION NEEDLE WITH LUER ADAPTER, A PHLEBOTOMIST ENGAGED THE SAFETY MECHANISM, THE SAFETY MECHANISM FELL OFF, AND SHE OBTAINED A CONTAMINATED NEEDLE STICK INJURY. THE PHLEBOTOMIST RECEIVED POST EXPOSURE LAB WORK. NO OTHER MEDICAL INTERVENTIONS OR PROPHYLAXIS WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382657 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER HYPODERMIC NEEDLE FMI BECTON, DICKINSON & CO., (BD) 6083663

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention