BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOCK SYRINGE

    MDR report key: 8731593 · Received June 25, 2019

    Report

    Report Number
    3003152976-2019-00417
    Event Type
    Malfunction
    Date Received
    June 25, 2019
    Date of Event
    June 10, 2019
    Report Date
    August 13, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903012299
    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: TWO PHOTOS WERE 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 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 108 UNITS OF THE THREE LOTS MANUFACTURED PREVIOUSLY TO THIS LOT AND 108 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 BD PLASTIPAK¿ LUER-LOCK SYRINGE WAS DISCOLORED. THIS OCCURRED ON 2000 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PICTURED ITEM ATTACHED HAS YELLOW PLASTIC PACKAGING, THIS IS BEING USED IN A NON-STERILE JOB AND REQUIRES INTACT PACKAGING. WE ARE UNABLE TO USE APPROX 2000EA OF LOT 1811217 FOR THIS JOB TODAY. ALTHOUGH WE CAN USE THIS ITEM IN UNWRAPPED JOBS LATER THIS MONTH. THE STOCK HAS NOT EXPIRED. ITEM DESCRIPTION VENDOR ITEM SYRINGE, 30ML LUER LOCK 301229.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PLASTIPAK¿ LUER-LOCK SYRINGE WAS DISCOLORED. THIS OCCURRED ON 2000 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PICTURED ITEM ATTACHED HAS YELLOW PLASTIC PACKAGING, THIS IS BEING USED IN A NON-STERILE JOB AND REQUIRES INTACT PACKAGING. WE ARE UNABLE TO USE APPROX 2000EA OF LOT 1811217 FOR THIS JOB TODAY. ALTHOUGH WE CAN USE THIS ITEM IN UNWRAPPED JOBS LATER THIS MONTH. THE STOCK HAS NOT EXPIRED. ITEM DESCRIPTION VENDOR ITEM . SYRINGE, 30ML LUER LOCK 301229.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    526623 BD PLASTIPAK LUER-LOCK SYRINGE CONVENTIONAL SYRINGE FMF BECTON DICKINSON, S.A. 1811217 00382903012299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other