BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE SCHAEDLER W/KV AG 5% SB 90MM 20

    MDR report key: 12092593 · Received June 30, 2021

    Report

    Report Number
    9680577-2021-00024
    Event Type
    Malfunction
    Date Received
    June 30, 2021
    Date of Event
    June 1, 2021
    Report Date
    December 27, 2021
    Manufacturer
    BECTON DICKINSON GMBH
    Product Code
    JSJ
    PMA / PMN Number
    K760460
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY IT WAS REPORTED THAT TWO PRODUCTS WERE FOUND IN ONE BOX: SCHAEDLER KANAMYCIN-VANCOMYCIN AGAR WITH 5% SHEEP BLOOD AND COLUMBIA AGAR WITH 5% SHEEP BLOOD. COMPLAINT HISTORY REVIEW: THE COMPLAINT TRENDS WERE REVIEWED. THERE WERE NO SIMILAR COMPLAINTS RECEIVED ON THE REPORTED LOT NUMBER. THEREFORE, A TREND COULD NOT BE IDENTIFIED. DHR REVIEW: THE BATCH HISTORY REVIEW DID NOT INDICATE ANY DISCREPANCIES. ALL RELEASE TESTING WAS SATISFACTORY AND NO DEVIATIONS WERE OBSERVED. THE REPORTED PRODUCTS WERE PRODUCED ON TWO CONSECUTIVE DAYS ON LINE 3. ALTHOUGH, A LINE CLEARANCE WAS PERFORMED AND WAS DOCUMENTED WITHIN THE BATCH HISTORY RECORD, A MIXTURE OF BOTH PRODUCTS COULD NOT BE COMPLETELY EXCLUDED. LABELING/ PACKAGING REVIEW: A PACKAGING AND LABELING REVIEW WAS PERFORMED FOR BOTH PRODUCTS. A DEVIATION COULD NOT BE IDENTIFIED. SAMPLE ANALYSIS: A PICTURE SAMPLE WAS PROVIDED SHOWING TWO DIFFERENT PRODUCTS: SCHAEDLER KANAMYCIN-VANCOMYCIN AGAR WITH 5% SHEEP BLOOD AND COLUMBIA AGAR WITH 5% SHEEP BLOOD. RETAIN SAMPLES WERE ANALYZED. NO DEVIATON WAS DETECTED. INVESTIGATION CONCLUSION: AT THIS STAGE OF OUR INVESTIGATION, WE HAVE EXCLUDED ANY SYSTEMIC FAILURE IN OUR MANUFACTURING PROCESS. DURING INVESTIGATION IT WAS IDENTIFIED THAT BOTH AFFECTED PRODUCTS WERE PRODUCED ON TWO CONSECUTIVE DAYS ON THE SAME LINE. ALTHOUGH A LINE CLEARANCE WAS PERFORMED AND DOCUMENTED, A MIXTURE OF BOTH PRODUCTS COULD NOT BE COMPLETELY RULED OUT BASED ON THE PROVIDED PICTURE. AS ALL PLATES ARE BEING PINTED INDIVIDUALLY WITH THEIR PRODUCT NAME, ARTICLE AND BATCH NUMBER, THE ALL OVER RISK WAS DEEMED TO BE LOW. HOWEVER, AS IT IS POSSIBLE THAT ONE STACK OF THE PREVIOUSLY PRODUCED PRODUCT WAS INCLUDED IN THE BOX OF THE OTHER PRODUCT, THE OPERATORS WERE INFORMED ABOU THIS ISSUE. EVALUATION RESULTS: BASED ON THE INVESTIGATION AND THE PROVIDED PICTURES, THE COMPLAINT WAS CONFIRMED. A TREND COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILE USING 10 PLATE SCHAEDLER W/KV AG 5% SB 90MM 20 MIXED PRODUCTS WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CLIENT RECEIVED A PACKET OF KANA-VANCO MEDIA AT REFERENCE 254023. WITHIN THE PACKAGE OF 20 MEDIA THE CLIENT FOUND 10 COL-S MEDIA THAT SHOULD NOT BE THERE. "

    Additional Manufacturer Narrative · 1

    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 PLATE SCHAEDLER W/KV AG 5% SB 90MM 20 CATALOG NUMBER 221555 WHICH HAS 510K NUMBER K760460.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE USING 10 PLATE SCHAEDLER W/KV AG 5% SB 90MM 20 MIXED PRODUCTS WERE OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE CLIENT RECEIVED A PACKET OF KANA-VANCO MEDIA AT REFERENCE (B)(4). WITHIN THE PACKAGE OF 20 MEDIA THE CLIENT FOUND 10 COL-S MEDIA THAT SHOULD NOT BE THERE. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    991426 PLATE SCHAEDLER W/KV AG 5% SB 90MM 20 CULTURE MEDIA, SELECTIVE AND NON-DIFFERENTIAL JSJ BECTON DICKINSON GMBH 1097762

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown