BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 16876486 · Received May 5, 2023

    Report

    Report Number
    3003152976-2023-00159
    Event Type
    Malfunction
    Date Received
    May 5, 2023
    Date of Event
    January 9, 2023
    Report Date
    May 24, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 24-MAY-2023 H6: INVESTIGATION SUMMARY ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A PARTICLE WAS OBSERVED OVER THE PLUNGER. USING MAGNIFICATION, THE SAMPLE WAS IDENTIFIED TO BE A POLYPROPYLENE PARTICLE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2012056, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. MANUFACTURING FOR THIS PRODUCT IS PERFORMED IN A CLEAN ROOM WHICH IS KEPT UNDER A POSITIVE PRESSURE TO REDUCE THE CHANCE OF FOREIGN MATTER. THE ASSEMBLY STATION HAS A DE-IONIZER AND VACUUM SYSTEM USED TO REMOVE ANY PARTICLES INSIDE THE BARREL. 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. THE AREAS WHERE PIECES RUN IN MANUFACTURING AREA ARE PROTECTED TO AVOID DAMAGE ON THE PRODUCT AND REDUCE PARTICLES FROM GENERATING. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, THE PARTICLE LIKELY GENERATED DURING THE ASSEMBLY PROCESS DUE TO FRICTION DURING MOVEMENT OF THE DEVICE WITHIN THE MANUFACTURING EQUIPMENT. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    E1. INITIAL REPORTER ADDR 1: PLACE (B)(6) H3. 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 · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING SYRINGES OF INTRATHECAL METHOTREXATE, THE PREPARERS OBSERVED PARTICLES IN THE BODY OF THE SYRINGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN FLUID PATH. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN PREPARING SYRINGES OF INTRATHECAL METHOTREXATE, THE PREPARERS OBSERVED PARTICLES IN THE BODY OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1692410 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown