BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE

    MDR report key: 17063909 · Received June 5, 2023

    Report

    Report Number
    3003152976-2023-00215
    Event Type
    Malfunction
    Date Received
    June 5, 2023
    Date of Event
    May 10, 2023
    Report Date
    June 21, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 20-JUN-2023 . H6: INVESTIGATION SUMMARY ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, IT CAN BE OBSERVED EMBEDDED FOREIGN MATTER IN THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2202096, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THIS DEFECT APPEARED DUE TO THE INJECTION OF BURNT MATERIAL GENERATED DURING MOLDING PROCESS. BEFORE THE INJECTION MACHINE IS RESTARTED UP IT IS PURGED UNTIL THE MATERIAL IS ACCEPTABLE REJECTING THE FIRST PIECES. INJECTION MACHINES ARE PERIODICALLY SUBJECTED TO MAINTENANCE AND CLEANING PROGRAM. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE PISTON HAD FOREIGN MATTER ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A SYRINGE IN WHICH, AFTER EXTRACTING CYTOSTATICS, WE HAVE OBSERVED THAT THE PISTON IS "DIRTY". DURING USE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE PISTON HAD FOREIGN MATTER ON IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A SYRINGE IN WHICH, AFTER EXTRACTING CYTOSTATICS, WE HAVE OBSERVED THAT THE PISTON IS "DIRTY". DURING USE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1189032 BD PLASTIPAK¿ SYRINGE WITH DETACHED BD MICROLANCE¿ 3 NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2202096

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown