BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK SYRINGE

    MDR report key: 8751219 · Received July 1, 2019

    Report

    Report Number
    3003152976-2019-00435
    Event Type
    Malfunction
    Date Received
    July 1, 2019
    Date of Event
    June 4, 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
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: 10 SEALED SAMPLES WERE RETURNED 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 1811217. 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. 108 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 THREE LOTS MANUFACTURED AFTER THIS LOT NOT FINDING ANY DEFECTIVE BLISTER. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS A YELLOW DISCOLORATION OBSERVED ON THE PACKAGING. THERE ARE 10 SYRINGES WITH THIS CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW DISCOLORATION OBSERVED ON PACKAGING.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE OF THE BD PLASTIPAK¿ LUER-LOK¿ SYRINGE THERE WAS A YELLOW DISCOLORATION OBSERVED ON THE PACKAGING. THERE ARE 10 SYRINGES WITH THIS CONDITION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: YELLOW DISCOLORATION OBSERVED ON PACKAGING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    543474 BD PLASTIPAK LUER-LOK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1811217

    Patients

    Seq Age Sex Outcome Treatment
    1 Other