BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK ¿ - 3-PIECE SYRINGE

    MDR report key: 16853549 · Received May 2, 2023

    Report

    Report Number
    3003152976-2023-00152
    Event Type
    Malfunction
    Date Received
    May 2, 2023
    Date of Event
    April 7, 2023
    Report Date
    May 2, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 27-APR-2023. H6: INVESTIGATION SUMMARY: ONE 50 ML SYRINGE AND PHOTO RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, EMBEDDED FOREIGN MATTER IS OBSERVED ON THE BARREL INSIDE THE FLUID PATH. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2211019, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS 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. POSSIBLE ROOT CAUSE IS GENERATED DURING THE MOLDING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY WE FOUND A SYRINGE WITH A BATCH OF SYRINGE, 50 ML LUER-LOCK LATEX-FREE THAT IS CONTAMINATED. THIS IS ITEM NUMBER 300865 WITH LOT NUMBER 2211019.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK ¿ - 3-PIECE SYRINGE EXPERIENCED FOREIGN MATTER IN DEVICE CANNULA. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: TODAY WE FOUND A SYRINGE WITH A BATCH OF SYRINGE, 50 ML LUER-LOCK LATEX-FREE THAT IS CONTAMINATED. THIS IS ITEM NUMBER 300865 WITH LOT NUMBER 2211019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124398 BD PLASTIPAK ¿ - 3-PIECE SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown