BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTICPACK SYRINGE

    MDR report key: 17375459 · Received July 22, 2023

    Report

    Report Number
    3003152976-2023-00292
    Event Type
    Malfunction
    Date Received
    July 22, 2023
    Date of Event
    June 29, 2023
    Report Date
    September 13, 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

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H3. 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: 24-AUG-2023. H6: INVESTIGATION SUMMARY: BOTH PHOTOS AND ONE PHYSICAL SAMPLE HAVE BEEN PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, A LEAKAGE PAST THE STOPPER RIBS IS OBSERVED. THERE WAS NO DAMAGE FOUND IN THE BARREL OR ANY OTHER COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE LEAK OBSERVED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2212061, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. 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, INCLUDING LEAKAGE TESTING. THE RETURNED SAMPLE UNDERWENT THESE SAME TESTS AND FOUND PRODUCT MET REQUIRED SPECIFICATIONS. GIVE THERE WAS NO VISIBLE DAMAGE OR DEFECT WITHIN THE PRODUCT AND DEVICE RECORDS DID NOT REVEAL ANY QUALITY ISSUES, WE CANNOT IDENTIFY A DEFINITIVE ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    CORRECTION: B5: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE BD PLASTICPACK SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PACKAGING OF NACL AEB 5% WASHING SOLUTION FOR MTI-PP PRODUCTION, SYRINGE LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTICPACK SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PACKAGING OF NACL AEB 5% WASHING SOLUTION FOR MTI-PP PRODUCTION, SYRINGE LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTICPACK SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PACKAGING OF NACL AEB 5% WASHING SOLUTION FOR MTI-PP PRODUCTION, SYRINGE LEAKAGE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTICPACK SYRINGE EXPERIENCED LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH TO ENGLISH: PACKAGING OF NACL AEB 5% WASHING SOLUTION FOR MTI-PP PRODUCTION, SYRINGE LEAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2256159 BD PLASTICPACK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212061

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown