BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE TSA SB 5% 100MM 10EA

    MDR report key: 15674508 · Received October 26, 2022

    Report

    Report Number
    9614033-2022-00089
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    October 12, 2022
    Report Date
    January 13, 2023
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY: A CLAIM WAS RECEIVED FROM THE CLIENT GRUPO LAROCHELLE WHERE CONTAMINATION WAS REPORTED IN A UNIT WITH CATALOG PLATE 220150 LOT 2201487 FOR WHICH THE FOLLOWING WAS REVIEWED: REVIEW OF THE BATCH FILE: VERIFYING THAT ALL THE PROCESSES WERE FOLLOWED EFFECTIVELY DURING THE MANUFACTURE OF THE PRODUCT, LIKEWISE THE BATCH WAS ANALYZED BY THE QUALITY CONTROL DEPARTMENT AND THE RESULTS WERE SATISFACTORY FOR THE RELEASE OF THE BATCH. ANALYSIS OF CLIENT SAMPLES: THE CLIENT SENDS A PHOTOGRAPH WHERE THE IDENTIFICATION OF THE PACKAGE BAG THAT CORRESPONDS TO THE REPORTED BATCH CAN BE OBSERVED, AS WELL AS A UNIT WITH THE PRESENCE OF BACTERIAL CONTAMINATION. THE ARRANGEMENT OF THE COLONIES PRESENT SUGGESTS THAT THE CONTAMINATION IS DUE TO THE PARTIAL OPENING OF THE PLATE IN A CONTAMINATED ENVIRONMENT, SINCE THE COLONIES ARE CLOSE TO THE EDGE OF THE PLATE AND ARE NOT EVENLY DISTRIBUTED. THIS TYPE OF GROWTH CAN ALSO BE OBSERVED BY SPLASHING, FOR EXAMPLE FROM THE CONDENSATION WATER ITSELF, HOWEVER IN THIS PHOTOGRAPH ITS PRESENCE IS NOT OBSERVED. ANALYSIS OF RETENTION SAMPLES: THE RETENTION SAMPLES (40UN) WERE REVIEWED WITHOUT DETECTING THE PRESENCE OF MICROBIAL GROWTH NEITHER ON THE SURFACE NOR INTERNALLY. CONCLUSION: IT IS CONCLUDED THAT THE EVENT REPORTED BY THE CLIENT IS CLASSIFIED AS CONFIRMED BASED ON THE PHOTOGRAPHIC EVIDENCE PROVIDED BY THE CLIENT, HOWEVER, A ROOT CAUSE ATTRIBUTABLE TO FAILURE IN ANY OF THE CONTROLS IN THE PROCESSES DURING THE PRODUCTION PROCESS WAS NOT IDENTIFIED. OR STORAGE WHILE THE PRODUCT WAS KEPT UNDER THE CUSTODY OF BD. IT IS WORTH MENTIONING THAT THE SURFACE CONTAMINATION DEFECT OF THE PPM MEDIUM PREPARED PRODUCT IS CLASSIFIED AS A MAJOR DEFECT WITH AN AQL OF 2.5, SO A SINGLE CONTAMINATED PLATE IS ACCEPTABLE WITHIN THE SPECIFICATION CRITERIA.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE TSA SB 5% 100MM 10EA CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "PLATES IN BAD CONDITIONS." HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING PLATE TSA SB 5% 100MM 10EA CONTAMINATION OCCURRED. THE FOLLOWING INFORMATION WAS REPORTED BY THE INITIAL REPORTER: "PLATES IN BAD CONDITIONS." HAZARD, INJURY OR ERRONEOUS RESULTS? NO. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2510363 PLATE TSA SB 5% 100MM 10EA CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON DE MEXICO 2201487

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown