BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿

    MDR report key: 8834073 · Received July 26, 2019

    Report

    Report Number
    3003152976-2019-00482
    Event Type
    Malfunction
    Date Received
    July 26, 2019
    Date of Event
    July 10, 2019
    Report Date
    September 6, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: ONE SAMPLE AND EIGHT PHOTOS WERE PROVIDED FOR INVESTIGATION. VISUAL INSPECTION OF THE PRODUCT REVEALED A FOREIGN MATTER INSIDE THE SEALED BLISTER PACKAGING. THE PARTICLES WERE EXTRACTED AND USING MAGNIFICATION WERE IDENTIFIED TO CONSIST OF POLYPROPYLENE PARTICLES AND DIRT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 1904003, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. WE PERFORM INSPECTIONS AND CLEARLY DEFINED CLEANING PROCEDURES AFTER PRODUCTION OF EACH LOT. WHILE WE COULD NOT IDENTIFY A DIRECT ISSUE, IT IS LIKELY THE POLYPROPYLENE AND DIRT PARTICLES GENERATED DURING THE TRANSPORT PROCESS OF THE PRODUCT WITHIN THE MANUFACTURING EQUIPMENT, ATTACHING TO THE BARREL. BASED ON THE PREVENTIVE MEASURES IN PLACE AND THE CURRENT INSPECTION PROCESS, THIS IS BELIEVED TO BE AN ISOLATED ISSUE WITH AN UNLIKELY RECURRENCE. MANUFACTURING PERSONNEL HAVE BEEN MADE AWARE OF THIS INCIDENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT HAS BEEN REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HAS BEEN FOUND DISCOLORED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: I HAVE A COMPLAINT REGARDING THE POSIFLUSH SP 10ML. THE BATCH NUMBER IS 1904003. THE PACKAGE HAS NOT BEEN OPENED AND THE OUTSIDE OF THE SYRINGE ( WITHIN THE PACKAGE) IS GREEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 HAS BEEN REPORTED THAT THE BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ HAS BEEN FOUND DISCOLORED BEFORE USE. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: I HAVE A COMPLAINT REGARDING THE POSIFLUSH SP 10ML. THE BATCH NUMBER IS 1904003 . THE PACKAGE HAS NOT BEEN OPENED AND THE OUTSIDE OF THE SYRINGE (WITHIN THE PACKAGE) IS GREEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624047 BD PLASTIPAK¿ HYPODERMIC SYRINGE LUER LOK¿ SYRINGE WITH HYPODERMIC NEEDLE FMI BECTON DICKINSON, S.A. 1904003

    Patients

    Seq Age Sex Outcome Treatment
    1 Other