BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II)

    MDR report key: 14317182 · Received May 7, 2022

    Report

    Report Number
    9680577-2022-00064
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 7, 2022
    Report Date
    July 12, 2022
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSG
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6 INVESTIGATION SUMMARY : THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR COMPLAINT (B)(4) AGAINST TRYPTICASE¿ SOY AGAR II WITH 5% SHEEP BLOOD, CATALOG NUMBER 254053, LOT NUMBER 2039481. EVENT DESCRIPTION: IT WAS REPORTED THAT THE PLATES WOULD HAVE DIFFERENT SHADES IN THE COLORATION OF THE MEDIA. FURTHERMORE, LEAKAGE AND CONTAMINATION WERE REPORTED. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED, AND NO SIMILAR COMPLAINTS WERE IDENTIFIED FOR THIS BATCH NUMBER. THEREFORE, A TREND COULD NOT BE IDENTIFIED. SAMPLE ANALYSIS: PICTURE SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE PICTURES, THE SURFACE OF THE MEDIA WAS FOUND TO BE UNEVEN, AND MOISTURE WAS DETECTED. THE SHADE OF THE MEDIUM IS DIFFERENT IN SOME PLATES. CONTAMINATION WAS NOT DETECTED. THE RETAIN SAMPLES WERE REVIEWED AND NO DEVIATION WAS DETECTED. EVALUATION SUMMARY AND INVESTIGATION CONCLUSION: BD MANUFACTURES VARIOUS PREPARED PLATED MEDIA TYPES, ALL OF WHICH CONTAIN AROUND 95 % WATER. MOISTURE, SURFACE ISSUES AND COLOR VARIATIONS WITHIN THE PLATES CAN BE CAUSED BY VARIOUS ENVIRONMENTAL FACTORS LINKED TO TRANSPORTATION AND STORAGE. SINCE THE RETAIN SAMPLES SHOWED NO DEVIATION, ALL QC RELEASE SPECIFICATIONS FOR THE PRODUCT WERE FULFILLED AND, ACCORDING TO THE COMPLAINT TRENDING, THIS INCIDENT CAN BE HANDLED AS ISOLATED ISSUE. NO DEVIATIONS COULD BE IDENTIFIED NEITHER DURING IN-PROCESS CONTROL NOR QUALITY CONTROL (QC) RELEASE. REVIEW OF THE COMPLAINT HISTORY SHOWED NO SIMILAR COMPLAINTS; THEREFORE, A TREND WAS NOT IDENTIFIED. BASED ON THE PICTURES PROVIDED, THIS COMPLAINT CAN BE CONFIRMED FOR COLOR VARIATION, UNEVEN SURFACE AND MOISTURE. A CONTAMINATION WAS NOT DETECTED AND THEREFORE, NOT CONFIRMED. SINCE ANY SYSTEMIC FAILURE CAN BE EXCLUDED FROM THE VALIDATED MANUFACTURING PROCESS, A DEFINITE ROOT CAUSE WAS NOT IDENTIFIED. BD WILL CONTINUE TO MONITOR INCOMING COMPLAINTS FOR SIMILAR DEFECT TYPES. H3 OTHER TEXT : NA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THE CUSTOMER OBSERVED DISCOLORATION, LEAKING AGAR, AND BIOLOGICAL CONTAMINATION. THIS EVENT OCCURRED 15 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. PLATES ALL HAD DIFFERENT COLORS (LIGHT RED, DARK RED). 2. BLOOD LEAKED FROM THE PLATES. 3. THE PLATES WERE PARTLY OVERGROWN WITH SOMETHING (CONTAMINATION). 4. SOME PLATES WERE TRANSPARENT. 5. PH VALUE WAS NOT RECORDED".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PRIOR TO USING BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) THE CUSTOMER OBSERVED DISCOLORATION, LEAKING AGAR, AND BIOLOGICAL CONTAMINATION. THIS EVENT OCCURRED 15 TIME(S). THERE IS NO INDICATION THAT FALSE RESULTS WERE REPORTED TO HEALTH CARE PRACTITIONERS. THERE IS NO INDICATION OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. PLATES ALL HAD DIFFERENT COLORS (LIGHT RED, DARK RED). 2. BLOOD LEAKED FROM THE PLATES. 3. THE PLATES WERE PARTLY OVERGROWN WITH SOMETHING (CONTAMINATION). 4. SOME PLATES WERE TRANSPARENT. 5. PH VALUE WAS NOT RECORDED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079133 BD BBL¿ TRYPTICASE¿ SOY AGAR WITH 5% SHEEP BLOOD (TSA II) CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON GMBH 2039481

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown