BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTEC LYTIC/10 ANAEROBIC/F MEDIUM

    MDR report key: 1437084 · Received August 11, 2009

    Report

    Report Number
    1119779-2009-00008
    Event Type
    Injury
    Date Received
    August 11, 2009
    Date of Event
    July 29, 2009
    Report Date
    August 11, 2009
    Manufacturer
    BD CARIBE, LTD.
    Product Code
    JSL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    RETENTION SAMPLES FROM THE SAME LOT WERE VISUALLY INSPECTED FOR ANY BROKEN AND/OR CRACKED VIALS. ALL RESULTS WERE SATISFACTORY. REVIEW OF THE BATCH HISTORY RECORD DID NOT IDENTIFY ABNORMALITIES AS RELATED TO THIS ISSUE. ALTHOUGH BD IS UNABLE TO CONFIRM ANY ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS EVENT, WE WILL CONTINUE TO CLOSELY MONITOR THIS TYPE OF ISSUE. BD WILL CONTINUE TO EDUCATE THE CUSTOMER CONCERNING PROPER HANDLING OF BACTEC BOTTLES AND ANY BREAKAGE THAT MAY OCCUR.

    Description of Event or Problem · 1

    A PHLEBOTOMIST PICKED UP TWO BLOOD CULTURE BOTTLES TO TAKE THEM TO ANOTHER ROOM TO DRAW A PATIENT. ONE OF THE BOTTLES SEEMED TO COLLAPSE IN HIS HAND. THE TECH INSTINCTIVELY GRIPPED TIGHTER, RESULTING IN THE TWO DEEP LACERATIONS THAT REQUIRED SIXTEEN SUTURES AND A TETANUS SHOT. THE BOTTLE DID NOT CONTAIN ANY BLOOD OR BODY FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BACTEC LYTIC/10 ANAEROBIC/F MEDIUM JSL BD CARIBE, LTD. 8354757

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention