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: 5392246 · Received January 26, 2016

    Report

    Report Number
    1024879-2016-00003
    Event Type
    Injury
    Date Received
    January 26, 2016
    Date of Event
    January 8, 2016
    Report Date
    January 12, 2016
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    FMI
    PMA / PMN Number
    D038055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE LOT #: UNKNOWN. TWO POTENTIAL LOT NUMBERS WERE PROVIDED FOR THIS INCIDENT; 5235748 & 5230715. MEDICAL DEVICE EXPIRATION DATE: 5232748: 8/31/2020; 5230715: 8/31/2020. DEVICE MANUFACTURE DATE: 5232748: 8/20/2015; 5230715: 8/18/2015. RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES FOR THE POTENTIAL LOT NUMBERS 5235748 & 5230715. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. HOWEVER, ALTHOUGH IT IS UNABLE TO BE CONFIRMED, OUR QUALITY ENGINEER NOTES THAT A POTENTIAL CAUSE FOR THIS INCIDENT MAY BE A VALVE FAILURE AT THE GEL DISPENSE OPERATION. A SAMPLE IS NOT AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING A 21 G X 1.25 IN BD ECLIPSE BLOOD COLLECTION NEEDLE WITH LUER ADAPTER TO DRAW LABS, A PHLEBOTOMIST ACTIVATED THE SAFETY MECHANISM, HEARD AN AUDIBLE CLICK BUT STATED THAT THE NEEDLE WAS NOT FULLY COVERED BY THE SAFETY SHIELD. THIS RESULTED IN A CONTAMINATED NEEDLE STICK INJURY TO THE PHLEBOTOMIST. THE SOURCE PATIENT IS (B)(6) AND BOTH THE PATIENT AND THE PHLEBOTOMIST RECEIVE ROUTINE POST EXPOSURE LAB WORK. THE TESTS RESULTS WERE (B)(6) AND THE PHLEBOTOMIST WAS CURRENT ON HER (B)(6) IMMUNIZATION THUS NO ADDITIONAL MEDICAL TREATMENT OR PROPHYLAXIS WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49425 21 G X 1.25 IN BD ECLIPSE¿ BLOOD COLLECTION NEEDLE WITH LUER ADAPTER SAMPLE NEEDLE FMI BECTON, DICKINSON & CO., (BD) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention