BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE MUELLER HINTON II AGAR 20 EA

    MDR report key: 14466310 · Received May 21, 2022

    Report

    Report Number
    1119779-2022-00746
    Event Type
    Malfunction
    Date Received
    May 21, 2022
    Date of Event
    April 26, 2022
    Report Date
    May 24, 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

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD DS HEADQUARTERS IN (B)(4) HAS BEEN LISTED, AND THE SPARKS FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE IS NO 510(K) FOR THIS DEVICE AS IT IS MANUFACTURED OUTSIDE THE US AND NOT SOLD IN THE US BUT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED DEVICE BD BBL¿ MUELLER HINTON II AGAR CATALOG NUMBER 211438 WHICH IS A PREAMENDMENT DEVICE.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 06-MAY-2022. INVESTIGATION SUMMARY: RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING CONTAMINATION. WE CONFIRMED THE ISSUE AS A REPORT FROM RETURNED SAMPLE. PHOTO PROVIDED SHOWS CONTAMINATION AS WELL. THE ISSUE WAS CONTAMINATION. NO COMPLAINT HISTORY. NO ISSUE IN DEVICE HISTORY RECORD REVIEW OR RETENTION SAMPLES. NO TREND.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR 20 EA BIOLOGICAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, THE MEDIA WAS FOUND TO BE CONTAMINATED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE MUELLER HINTON II AGAR 20 EA BIOLOGICAL CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ACCORDING TO THE CUSTOMER'S REPORT, THE MEDIA WAS FOUND TO BE CONTAMINATED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583435 PLATE MUELLER HINTON II AGAR 20 EA CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGAR/BROTH JTZ BECTON, DICKINSON & CO. (SPARKS) 2039414

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown