BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHEEP BLOOD AGAR, STRENGTH 5 PERCENT

    MDR report key: 6568719 · Received May 15, 2017

    Report

    Report Number
    MW5069801
    Event Type
    Malfunction
    Date Received
    May 15, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 12, 2017
    Manufacturer
    REMEL
    Product Code
    JSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    TWO DIFFERENT LOTS OF SHEEP BLOOD AGAR OVER THREE DIFFERENT SHIPMENTS CONTAMINATED WITH DIFFERENT TYPES OF MOLD GROWTH. PRODUCT DESCRIPTION: REMEL 5 PERCENT BLOOD AGAR PRODUCT CODE R01202. AFFECTED LOT NUMBERS 140587 AND 137952. SHEEP BLOOD AGAR IS GENERAL MEDIA FOR MICROBIOLOGY CULTURE GROWTH ON PATIENT SPECIMENS. THIS DIRECTLY AFFECTS PATIENT CARE AND SAFETY. THERAPY START DATE: (B)(6) 2017. THERAPY END DATE: (B)(6) 2017. DIAGNOSIS OR REASON FOR USE: GENERAL MICROBIOLOGY MEDIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349312 SHEEP BLOOD AGAR, STRENGTH 5 PERCENT SHEEP BLOOD AGAR, STRENGTH 5 PERCENT JSH REMEL 140587
    349313 SHEEP BLOOD AGAR, STRENGTH 5 PERCENT SHEEP BLOOD AGAR, STRENGTH 5 PERCENT JSH REMEL 137952

    Patients

    Seq Age Sex Outcome Treatment
    1 Other