BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16709810 · Received April 10, 2023

    Report

    Report Number
    3003152976-2023-00124
    Event Type
    Malfunction
    Date Received
    April 10, 2023
    Date of Event
    March 21, 2023
    Report Date
    April 27, 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

    INVESTIGATION SUMMARY: ONE SAMPLE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, BARREL IS DAMAGED, WHICH LIKELY CAUSED THE LEAKAGE PAST STOPPER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2212074, 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 ASSOCIATED WITH MISALIGNMENT IN THE ASSEMBLY PROCESS.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WE HAVE A BATCH OF LEAKING SYRINGES REF 300865. LOT 2212074. WE HAVE KEPT ONE SYRINGE FOR EXPERTISE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 2 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGES LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: WE HAVE A BATCH OF LEAKING SYRINGES REF 300865. LOT 2212074. WE HAVE KEPT ONE SYRINGE FOR EXPERTISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798777 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212074

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown