BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGES

    MDR report key: 14187554 · Received April 22, 2022

    Report

    Report Number
    3003152976-2022-00164
    Event Type
    Malfunction
    Date Received
    April 22, 2022
    Date of Event
    March 31, 2022
    Report Date
    May 4, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY ONE PHOTO SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO WAS EVALUATED AND A PARTICLE WAS OBSERVED OVER THE PLUNGER. THROUGH VISUAL INSPECTION, THE PARTICLE WAS IDENTIFIED TO BE A POLYPROPYLENE PARTICLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2012070, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED ISSUE. FINAL PRODUCTS IN THIS MANUFACTURING LINE, FOR THIS REFERENCE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. INJECTION MACHINES UNDERGO ROUTINE CLEANING AND MAINTENANCE ACCORDING TO PROCEDURE. MACHINE PARAMETERS WERE REVIEWED FOR LOT 2012070 AND WERE VERIFIED TO BE OPERATING WITHIN REQUIRED LIMITS. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE PARTICLE LIKELY GENERATED DURING THE MOLDING PROCESS DUE TO EITHER A FAILURE IN THE MOLD OR DUE TO FRICTION DURING MOVEMENT OF THE DEVICE WITHIN THE MANUFACTURING EQUIPMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES FOREIGN MATTER WAS FOUND IN THE FLUID PATH. THIS OCCURRED 11 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER "WE HAVE NOTICED A SLITHER/SWARF OF PLASTIC ON THE INSIDE OF THE NECK OF THE SYRINGE WHERE THE NEEDLE FITS TO THE LUER LOCK. THIS IS PROBLEMATIC AS IT CAN POTENTIALLY TRANSFER TO A FINISHED PRODUCT CONTAINER/ BAG...".

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PLASTIPAK¿ SYRINGES FOREIGN MATTER WAS FOUND IN THE FLUID PATH. THIS OCCURRED 11 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER "WE HAVE NOTICED A SLITHER/SWARF OF PLASTIC ON THE INSIDE OF THE NECK OF THE SYRINGE WHERE THE NEEDLE FITS TO THE LUER LOCK. THIS IS PROBLEMATIC AS IT CAN POTENTIALLY TRANSFER TO A FINISHED PRODUCT CONTAINER/ BAG..."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169984 BD PLASTIPAK¿ SYRINGES PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012070

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown