BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ ISOVITALEX¿ ENRICHMENT

    MDR report key: 16820053 · Received April 26, 2023

    Report

    Report Number
    1119779-2023-00480
    Event Type
    Malfunction
    Date Received
    April 26, 2023
    Date of Event
    April 7, 2023
    Report Date
    June 2, 2023
    Manufacturer
    BECTON, DICKINSON & CO. (SPARKS)
    Product Code
    JSK
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT 1119779-2023-00480 WAS SENT IN ERROR. THERE WAS NO REPORT OF SERIOUS INJURY, MEDICAL INTERVENTION, OR REPORTABLE DEVICE MALFUNCTION. THEREFORE THIS IS NOT CONSIDERED TO BE A REPORTABLE MALFUNCTION.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ ISOVITALEX¿ ENRICHMENT THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER REFERENCE (B)(4) OUR HOMEMADE PLATES ARE REJECTED ON QUALITY, THERE IS HARDLY ANY GROWTH. IN THE LAST SHIPMENT OF ISOVITALEX ENRICHMENT REFERENCE (B)(4) OUR HOMEMADE PLATES ARE REJECTED ON QUALITY , THERE IS HARDLY ANY GROWTH ON THE HAEMOPHILUS PLATES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING THE BD BBL¿ ISOVITALEX¿ ENRICHMENT THAT THERE WAS A PERFORMANCE ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER REFERENCE (B)(4) OUR HOMEMADE PLATES ARE REJECTED ON QUALITY, THERE IS HARDLY ANY GROWTH. IN THE LAST SHIPMENT OF ISOVITALEX ENRICHMENT REFERENCE (B)(4) OUR HOMEMADE PLATES ARE REJECTED ON QUALITY , THERE IS HARDLY ANY GROWTH ON THE HAEMOPHILUS PLATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1336516 BD BBL¿ ISOVITALEX¿ ENRICHMENT SUPPLEMENT, CULTURE MEDIA JSK BECTON, DICKINSON & CO. (SPARKS) 2299651

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown