BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK LUER-LOK 30 ML SYRINGE

    MDR report key: 8773890 · Received July 9, 2019

    Report

    Report Number
    3003152976-2019-00452
    Event Type
    Malfunction
    Date Received
    July 9, 2019
    Date of Event
    June 18, 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: THREE SEALED SAMPLES AND ONE PHOTO 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 PACKAGE 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. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND DURING USE WITH A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER HAS 12 BOXES OF SAME LOT NUMBER. ORDERED FROM DISTRIBUTOR - ONE LINK. RANDOM EACHES IN SOME BOXES HAVE A YELLOW COLORING AROUND THE SEAM EDGING OF PACKAGING ON THE CLEAR SIDE. OTHER BOXES FROM SAME LOT NUMBER HAVE NO AFFECTED PRODUCT."

    Additional Manufacturer Narrative · 1

    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 FOREIGN MATTER WAS FOUND DURING USE WITH A BD PLASTIPAK¿ LUER-LOK¿ 30 ML SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "CUSTOMER HAS 12 BOXES OF SAME LOT NUMBER. ORDERED FROM DISTRIBUTOR - ONE LINK. RANDOM EACHES IN SOME BOXES HAVE A YELLOW COLORING AROUND THE SEAM EDGING OF PACKAGING ON THE CLEAR SIDE. OTHER BOXES FROM SAME LOT NUMBER HAVE NO AFFECTED PRODUCT." 50 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565216 BD PLASTIPAK LUER-LOK 30 ML SYRINGE CONVENTIONAL SYRINGE FMF BECTON DICKINSON, S.A. 1811217 00382903012299

    Patients

    Seq Age Sex Outcome Treatment
    1 Other