BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 11388248 · Received February 26, 2021

    Report

    Report Number
    3003152976-2021-00112
    Event Type
    Malfunction
    Date Received
    February 26, 2021
    Date of Event
    February 3, 2021
    Report Date
    April 15, 2021
    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

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 3/1/2021. H.6. INVESTIGATION: ONE USED SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED AND A LEAKAGE PAST THE STOPPER RIBS WAS OBSERVED. THERE ARE NO DEFECTS OR DAMAGE THAT WAS NOTED ON THE SAMPLE OR SYRINGE COMPONENTS THAT COULD HAVE CONTRIBUTED TO THE LEAK. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2010050, 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, INCLUDING LEAKAGE TESTING AND TIGHTNESS TESTING TO VERIFY THE SEAL OF THE STOPPER. THE RETURNED SAMPLE UNDERWENT THESE TESTS AND IT WAS VERIFIED THE PRODUCT MET REQUIRED SPECIFICATION. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN SAMPLING THE SOLUTION WITH THE SYRINGE, THE STOPPER IS NOT SEALED AND THE MEDICINE LEAKS. THIS INCIDENT OCCURRED IN THE CONTEXT OF AN EXERCISE WITH EPPI (WATER FOR INJECTABLE PREPARATION), SO THERE WERE NO CLINICAL CONSEQUENCES.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN SAMPLING THE SOLUTION WITH THE SYRINGE, THE STOPPER IS NOT SEALED AND THE MEDICINE LEAKS. THIS INCIDENT OCCURRED IN THE CONTEXT OF AN EXERCISE WITH EPPI (WATER FOR INJECTABLE PREPARATION), SO THERE WERE NO CLINICAL CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281395 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE SYRINGE FMF BECTON DICKINSON, S.A. 2010050

    Patients

    Seq Age Sex Outcome Treatment
    1