BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.1L BD NEXT GENERATION SHARPS COLLECTOR

    MDR report key: 3093653 · Received May 1, 2013

    Report

    Report Number
    2243072-2013-00042
    Event Type
    Injury
    Date Received
    May 1, 2013
    Date of Event
    February 26, 2013
    Report Date
    May 1, 2013
    Manufacturer
    BD
    Product Code
    MMK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT HAS BEEN RECEIVED TO DATE, IF PRODUCT IS RETURNED, ANALYSIS WILL BE CONDUCTED.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT THE SHARPS CONTAINER WAS QUITE FULL SO SHE REMOVED IT FROM THE LOCKING BASE, SHOOK IT SO THAT THE SHARPS INSIDE THE CONTAINER WOULD SETTLE AND ALLOW FOR MORE SHARPS TO BE INSERTED, AND THEN REPLACED IT ON THE LOCKING BRACKET. THE CLINICIAN THEN ATTEMPTED TO DEPOSIT A SHARP, BUT DUE TO THE CONTAINER BEING QUITE FULL, THE CLOSURE MECHANISM DIDN'T DROP THE SHARP CORRECTLY AND THEN SPAT THE SHARP BACK OUT WHICH RESULTED IN INJURY TO THE CLINICIAN. FOLLOW UP BLOOD WORK FOR (B)(6) AND COUNSELLING WAS PROVIDED TO THE STAFF MEMBER. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2013, THE CLINICIAN RECEIVED THE BLOOD RESULTS AND MEDICAL TREATMENT WAS INDICATED. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189419 5.1L BD NEXT GENERATION SHARPS COLLECTOR SHARPS COLLECTOR MMK BD 2266934

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention