BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BBL CRYSTAL ENTERIC/NONFERMENTER ID KIT

    MDR report key: 2999458 · Received March 8, 2013

    Report

    Report Number
    1119779-2013-00001
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    JSS
    PMA / PMN Number
    K926018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO RETURNS WERE RECEIVED FOR INVESTIGATION. CRYSTAL KIT BASES AND LIDS FROM RETENTION SAMPLE WERE TESTED FOR LEAKAGE. NO LEAKAGE WAS PRESENT. THE COMPLAINT COULD NOT BE CONFIRMED. THERE ARE NO TRENDS FOR THIS TYPE OF ISSUE. NO ACTION WILL BE AT THIS TIME AND QUALITY WILL CONTINUE TO MONITOR COMPLAINTS FOR THIS TYPE OF COMPLAINT.

    Description of Event or Problem · 1

    A STAFF MEMBER WHO HAD HANDLED THE KIT INOCULATED A PANEL WITH A PATIENT SAMPLE AND CONTRACTED (B)(6) WHICH RESULTED IN HOSPITALIZATION. SHE WAS A SENIOR MEMBER OF STAFF WHO WAS AWARE OF THE RISKS AND HAND WASHING ETIQUETTE ETC. THE LAB STATES THAT WHEN THEY GOT THE CRYSTAL STRIP OUT OF THE HOT ROOM TO READ, THAT THE PLASTIC WAS WET AND AT THE TIME THOUGHT IT WAS CONDENSATION. THE STAFF MEMBER HAS FULLY RECOVERED. THE HSE HAVE BEEN INTO THE LABORATORY FOLLOWING THE RIDDOR REPORT AND ARE SATISFIED WITH LABORATORY SAFETY PRECAUTIONS. THE HOSPITAL STATED THAT THE EXACT CAUSE OF THE CONTAMINATION COULD NOT BE DETERMINED FROM THEIR RCA BUT WAS LIKELY TO BE THE CRYSTAL PANEL BEING CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98863 BBL CRYSTAL ENTERIC/NONFERMENTER ID KIT JSS BD DIAGNOSTIC SYSTEMS 2212457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| O