BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTEC LYTIC/10 ANAEROBIC/F MEDIUM

    MDR report key: 4476115 · Received January 29, 2015

    Report

    Report Number
    2647876-2015-00001
    Event Type
    Injury
    Date Received
    January 29, 2015
    Date of Event
    December 30, 2014
    Report Date
    January 5, 2015
    Manufacturer
    BD DIAGNOSTIC SYSTEMS
    Product Code
    MDB
    PMA / PMN Number
    K954925
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BACTEC LYTIC/10 ANAEROBIC/F CULTURE VIALS (PREREDUCED ENRICHED SOYBEAN-CASEIN DIGEST BROTH WITH CO2) ARE FOR ANAEROBIC BLOOD CULTURES. PRINCIPAL USE IS WITH THE BACTEC FLUORESCENT SERIES INSTRUMENTS FOR THE QUALITATIVE CULTURE AND RECOVERY OF ANAEROBIC MICROORGANISMS FROM BLOOD. BD QUALITY HAS COMPLETED THE INVESTIGATION FOR THE CUSTOMER COMPLAINT OF A BROKEN BACTEC LYTIC/10 ANAEROBIC/F BOTTLE. THIS COMPLAINT WAS CONFIRMED BASED ON THE PHOTOS TAKEN AND SUBMITTED BY THE CUSTOMER. THE BATCH NUMBER FOR THIS NOTIFICATION WAS UNKNOWN BUT BD QUALITY PERFORMED THE INVESTIGATION ON LYTIC/F ANAEROBIC MEDIA RETENTION SAMPLES IDENTIFIED BY THE CUSTOMER AS THE AVAILABLE BATCHES AT THEIR SITE AT THE TIME OF THE EVENT. THE BATCH NUMBERS REPORTED TO BE IN USE WERE: 4220860, 4142906, AND 4134845. BD QUALITY WAS UNABLE TO REPRODUCE CUSTOMER'S EXPERIENCE WITH THE BACTEC PRODUCT. SATISFACTORY RESULTS WERE OBTAINED FROM RETENTION SAMPLES WHEN VISUALLY INSPECTED FOR ANY BROKEN AND/OR CRACKED VIALS. BATCH HISTORY RECORD REVIEW DID NOT IDENTIFY ANY EVIDENCE FOR WHICH THE CUSTOMER SUBMITTED THE COMPLAINT BUT A REVIEW OF THE PHOTOS CONFIRMED THE BROKEN BOTTLE. A CUSTOMER LETTER WHICH OUTLINES PROPER HANDLING AND TRANSPORT GUIDELINES FOR BACTEC BOTTLES HAS BEEN PROVIDED TO THE CUSTOMER. A CROSS FUNCTIONAL TEAM CONTINUALLY MONITORS ALL PRODUCT COMPLAINTS FOR TRENDS.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT A BACTEC LYTIC/10 ANAEROBIC/F MEDIUM BOTTLE WAS PUT INTO AN INCUBATOR AFTER BEING FLAGGED POSITIVE AND WHEN A TECHNICIAN PICKED IT UP, THE TOP OF THE BOTTLE BROKE OFF. THE TECHNICIAN WAS EXPOSED TO BLOOD AND GLASS. TECHNICIAN WAS NOT WEARING PROTECTIVE EYE WEAR, GLASSES OR FACE SHIELD. PATIENT SAMPLE WAS CONFIRMED POSITIVE FOR E. COLI. PATIENT'S EYES WERE FLUSHED AND CHECKED FOR SCRATCHES IN THE ER; NO INJURIES WERE FOUND. TECHNICIAN WAS LATER SEEN BY AN EYE DOCTOR AND WAS DIAGNOSED WITH CONJUNCTIVITIS AND PUT ON ANTIBIOTIC DROPS. DOCTOR HAS CLEARED THE TECHNICIAN TO GO BACK TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68498 BACTEC LYTIC/10 ANAEROBIC/F MEDIUM MDB BD DIAGNOSTIC SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention