BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK SYRINGE

    MDR report key: 8691791 · Received June 12, 2019

    Report

    Report Number
    3003152976-2019-00391
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 28, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE PHOTO WAS PROVIDED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A YELLOW COLOR CAN BE OBSERVED ON THE BLISTER PACKS. A DEVICE HISTORY WAS PERFORMED AND FOUND NO NON-CONFORMANCES RELATED TO THE REPORTED ISSUE DURING PRODUCTION OF BATCH 1811241. RETAINED SAMPLES OF THE SAME LOT WERE INSPECTED, NOT FINDING ANY PRODUCT WITH THIS DEFECT. TESTING WAS PERFORMED IN ATTEMPTS TO RECREATE THIS ISSUE, ALL RESULTS WERE FOUND TO BE SATISFACTORY, NO YELLOW COLORING WAS OBSERVED. SAMPLES WERE TESTED TO ENSURE PRODUCT INTEGRITY, ALL PACKAGES TESTED WERE FOUND TO BE PROPERLY SEALED AND STERILITY RESULTS VERIFY THE PRODUCT REMAINS STERILE. BASED ON THE AVAILABLE INFORMATION, A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS CANNOT BE IDENTIFIED AT THIS TIME. THE FILM FOR THE REPORTED LOT IS PROVIDED BY A SUPPLIER WHOM WE HAVE NOTIFIED OF THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE. (B)(4) RETAINED SAMPLES OF THIS LOT HAS BEEN INSPECTED NOT FINDING ANY BLISTER WITH THIS DEFECT. ALSO IT HAS BEEN INSPECTED (B)(4) UNITS OF THE THREE LOTS MANUFACTURED PREVIOUSLY TO THIS LOT AND (B)(4) UNITS OF THE TWO LOTS MANUFACTURED AFTER THIS LOT NOT FINDING ANY DEFECTIVE BLISTER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE PACKAGING IS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING HAS YELLOW LIKE COLOR ON THE BORDER OF THE PACKAGING.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ SYRINGE PACKAGING IS DISCOLORED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PACKAGING HAS YELLOW LIKE COLOR ON THE BORDER OF THE PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    485081 BD PLASTIPAK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 1811241

    Patients

    Seq Age Sex Outcome Treatment
    1 Other