BEUDAMED
    FDA Adverse Event Injury Summary report: N

    25 G X 1 IN. BD ECLIPSE¿ NEEDLE, FOR USE WITH BD LUER-LOK¿ SYRINGE

    MDR report key: 5099580 · Received September 24, 2015

    Report

    Report Number
    8041187-2015-00005
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    July 20, 2015
    Report Date
    September 17, 2015
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FMI
    PMA / PMN Number
    K010188
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF THE REPORTED LOT NUMBER 4232128. CONCLUSION: WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED. DEVICE NOT RETURNED BY MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE ACTIVATING THE PINK SAFETY SHIELD OF A BD ECLIPSE NEEDLE, THE SHIELD BROKE OFF AND A CLINICIAN OBTAINED A CONTAMINATED NEEDLE STICK INJURY. IT WAS ALSO REPORTED THAT THIS INCIDENT OCCURRED IN AN (B)(6) CLINIC. THE CLINICIAN RECEIVED ROUTINE POST EXPOSURE LAB WORK AND WAS GIVEN THE PROPHYLACTIC MEDICATIONS TRUVADA AND RALTEGRAVIR. THE CLINICIAN TOOK THE FULL COURSE OF THE TRUVADA BUT THE RALTEGRAVIR WAS DISCONTINUED AFTER TWO DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633445 25 G X 1 IN. BD ECLIPSE¿ NEEDLE, FOR USE WITH BD LUER-LOK¿ SYRINGE HYPODERMIC NEEDLE FMI BECTON DICKINSON MEDICAL (SINGAPORE) 4232128

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention