BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 17454847 · Received August 3, 2023

    Report

    Report Number
    3003152976-2023-00315
    Event Type
    Malfunction
    Date Received
    August 3, 2023
    Date of Event
    July 17, 2023
    Report Date
    September 1, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 28-JUL-2023 INVESTIGATION SUMMARY: ONE PHYSICAL SAMPLE HAS BEEN PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PRODUCT WAS VISUALLY INSPECTED, 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 2210097, 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 SAMPLES 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS LEAKING OUT OF THE PLUNGER. THE FOLLOWING WAS RECIEVED BY THE INITIAL REPORTER: VERBATIM: SYRINGE USED WITH PROPOFOL. ONCE LOADED IN INFUSION PUMP, ANAESTHETIST REPORTED THAT THE PROPOFOL WAS COMING OUT OF THE PLUNGER RATHER THAN LUER-LOK END. RESULTED IN MEDICATION ON FLOOR RATHER THAN BEING DELIVERED TO THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE WAS LEAKING OUT OF THE PLUNGER. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: SYRINGE USED WITH PROPOFOL. ONCE LOADED IN INFUSION PUMP, ANAESTHETIST REPORTED THAT THE PROPOFOL WAS COMING OUT OF THE PLUNGER RATHER THAN LUER-LOK END. RESULTED IN MEDICATION ON FLOOR RATHER THAN BEING DELIVERED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1657626 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2210097

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown