BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD

    MDR report key: 15626824 · Received October 18, 2022

    Report

    Report Number
    1119779-2022-01315
    Event Type
    Malfunction
    Date Received
    October 18, 2022
    Date of Event
    October 13, 2022
    Report Date
    November 2, 2022
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JTZ
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS MDR, BD DS HEADQUARTERS IN SPARKS, MD HAS BEEN LISTED AS FUKUSHIMA IS AN OEM MANUFACTURING SITE. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: 251176. #2200283. WE COULDN'T CONFIRM THIS ISSUE AS A REPORT BECAUSE NO PHOTO AND RETURNED SAMPLE. COMPLAINT HISTORY WAS REVIEWED, AND NO OTHER COMPLAINT HAS BEEN TAKEN ON THIS LOT. AT THIS TIME. DEVICE HISTORY RECORD REVIEW (DHR) DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. IT INCLUDES BIOBURDEN TESTING. A VISUAL INSPECTION WAS PERFORMED ON 20 RETENTION SAMPLES OF THIS LOT. AS A RESULT, NO CONTAMINATION WAS OBSERVED. THE ROOT CAUSE FOR THIS COULD NOT BE DETERMINED WE WILL CONTINUE TO MONITOR THIS LOT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OCCURRENCE OF 10 WITH BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD MEDIA THAT WAS FOUND TO BE CONTAMINATED BEFORE UNPACKING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. THE CUSTOMER FOUND THAT THE MEDIA WAS CONTAMINATED BEFORE UNPACKING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS AN OCCURRENCE OF 10 WITH BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD MEDIA THAT WAS FOUND TO BE CONTAMINATED BEFORE UNPACKING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT CONTAMINATION OF THE MEDIA. THE CUSTOMER FOUND THAT THE MEDIA WAS CONTAMINATED BEFORE UNPACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306398 BBL - MUELLER HINTON AGAR WITH 5% SHEEP BLOOD CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 2200283

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown