BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16550875 · Received March 15, 2023

    Report

    Report Number
    3003152976-2023-00073
    Event Type
    Malfunction
    Date Received
    March 15, 2023
    Date of Event
    February 24, 2023
    Report Date
    April 12, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 14-MAR-2023. H.6. INVESTIGATION SUMMARY: ONE 50 LL SYRINGE RECEIVED FOR INVESTIGATION. UPON VISUAL EVALUATION, DAMAGED ON BARREL AND PLUNGER IS OBSERVED, THEREFORE THE INCIDENT IS CONFIRMED. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2211036, 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 AND LOT SIZE ARE SAMPLED AND THEY ARE SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING THE DIFFERENT MANUFACTURING SUB-PROCESSES ACCORDING TO PROCEDURES. BASED ON THE QUALITY TEAM'S INVESTIGATION, IT WAS DETERMINED THE DAMAGE WAS LIKELY CAUSED AS A RESULT OF THE PRODUCT JAMMING WITHIN THE MANUFACTURING EQUIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    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 THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER ROD WAS DAMAGED/BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THIS MESSAGE IS TO REPORT AN INCIDENT; WE HAVE FOUND THIS SYRINGE LOT 2211036 EXP 10/31/2027. WE HAVE NOT USED IT.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PLUNGER ROD WAS DAMAGED/BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM FRENCH: "THIS MESSAGE IS TO REPORT AN INCIDENT; WE HAVE FOUND THIS SYRINGE LOT 2211036 EXP 10/31/2027. WE HAVE NOT USED IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455712 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2211036

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown