BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BBL¿ PLATE TSA 5PRCT SB 90MM

    MDR report key: 17114438 · Received June 12, 2023

    Report

    Report Number
    9680577-2023-00025
    Event Type
    Malfunction
    Date Received
    June 12, 2023
    Date of Event
    May 17, 2023
    Report Date
    June 6, 2023
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSG
    PMA / PMN Number
    PREAMENDMENT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6 INVESTIGATION SUMMARY: THIS MEMO IS TO SUMMARIZE FINDINGS ON YOUR RECENT COMPLAINT (B)(4) AGAINST BD TRYPTICASETM SOY AGAR II WITH 5% SHEEP BLOOD, CATALOG NUMBER 254087 LOT NUMBER 3082825 WITH RESPECT TO CONTAMINATION. EVENT DESCRIPTION: THE CUSTOMER IS REPORTING CONTAMINATION FOR PRODUCT 254087 LOT NO. 3082825. ACCORDING TO THE CUSTOMER, AT LEAST 2 BOXES WITH A MINIMUM OF 15 PACKAGES OF PLATES ARE CONTAMINATED. COMPLAINT HISTORY REVIEW: COMPLAINT HISTORY WAS REVIEWED FOR THE PAST 12 MONTHS. ONE SIMILAR COMPLAINT HAS BEEN RECEIVED FOR CATALOG NUMBER 254087 WITHIN THIS PERIOD. BATCH HISTORY RECORD (BHR) REVIEW: THE BATCH HISTORY RECORD WAS REVIEWED. NO POTENTIAL DISCREPANCIES LEADING TO THIS DEFECT WERE REGISTERED. QC RELEASE TESTING WAS SATISFACTORY. SAMPLE ANALYSIS: THE RETAIN SAMPLES HAVE BEEN REVIEWED AND NO CONTAMINATION WAS OBSERVED AFTER STORAGE. HOWEVER, AFTER 7D OF INCUBATION, ONE COLONY GREW ON ONE PLATE. THE CONTAMINANT WAS IDENTIFIED AS PSEUDOMONAS FLUORESCENS. RETURN SAMPLES WERE NOT PROVIDED. THE CUSTOMER SHARED PICTURES ILLUSTRATING THE CONTAMINATION ON SEVERAL PLATES. EVALUATION SUMMARY: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. PLEASE NOTE THAT THIS PRODUCT DOES NOT HAVE AN SAL (STERILITY ASSURANCE LEVEL) CLAIM. IT IS FILLED ASEPTICALLY; THEREFORE, AN OCCURRENCE OF A CONTAMINATION EVENT CANNOT BE ENTIRELY RULED OUT. ALTHOUGH THIS CONTAMINATION LEVEL IS VERY LOW, WE CANNOT COMPLETELY EXCLUDE THAT A CUSTOMER MAY RECEIVE A CONTAMINATED PLATE. HOWEVER, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. INVESTIGATION CONCLUSION: BASED UPON OUR INVESTIGATION AND THE SUBMITTED PICTURES, THE COMPLAINT WAS CONFIRMED FOR CONTAMINATION. A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. SINCE THE COMPLAINT REVIEW DID NOT INDICATE A TREND, THERE ARE NO FURTHER CORRECTIVE ACTIONS INDICATED AT THIS TIME. HOWEVER, THE COMPLAINT WAS REGISTERED IN OUR DATABASE AND BD WILL CONTINUE TO MONITOR INCOMING REPORTS FOR THIS FAILURE MODE. WE ARE SORRY FOR THE INCONVENIENCE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS 15 PACKAGES OF CONTAMINATED BD BBL¿ PLATE TSA 5PRCT SB 90MM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YESTERDAY I RECEIVED WORD FROM COLLEAGUES THAT THERE WERE SOME CONTAMINATED BLOOD PLATES. UPON CLOSER INSPECTION, I HAVE NOW FOUND AT LEAST 2 BOXES WITH AT LEAST 15 PACKAGES OF PLATES THAT ARE CONTAMINATED. IT I DON'T KNOW FOR A MOMENT HOW BIG THE PROBLEM IS (I HAVEN'T OPENED ALL THE BOXES AND SOME PLATES HAVE ALREADY BEEN THROWN AWAY BY COLLEAGUES BUT I WOULD LIKE TO REPORT IT. IT IS REF NUMBER 254087, LOT NUMBER 3082825, SHELF LIFE UNTIL 03-07-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172131 BD BBL¿ PLATE TSA 5PRCT SB 90MM CULTURE MEDIA, NON-SELECTIVE AND NON-DIFFERENTIAL JSG BECTON DICKINSON GMBH 3082825

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown