BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 16696088 · Received April 6, 2023

    Report

    Report Number
    3003152976-2023-00120
    Event Type
    Malfunction
    Date Received
    April 6, 2023
    Date of Event
    March 15, 2023
    Report Date
    May 15, 2023
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 15-MAY-2023. H6: INVESTIGATION SUMMARY ONE SAMPLE AND PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL EVALUATION, LEAKAGE PAST STOPPER CAN BE OBSERVED. BARREL DO NOT PRESENT ANY DAMAGE THAT COULD HAVE DEFORMED THEIR SHAPE. THE STOPPER IS CORRECTLY ASSEMBLED, WHEN THE SYRINGE IS DISASSEMBLED THE PLUNGER DOES NOT SHOW ANY DEFECT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2212060, NO DEVIATIONS OR NON-CONFORMANCES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. RETAINED SAMPLES FROM THE SAME LOT WERE EVALUATED AND LEAKAGE TEST PERFORMED, NO DEFECTS OR LEAK WERE OBSERVED. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PROPOFOL PRIOR TO ADMINISTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ICU HAD AN ISSUE WITH A 50ML BD PLASTIPAK SYRINGE... THEY NOTED IT WAS LEAKING... ANESTHETIST WAS ADMINISTERING PROPOFOL AND SYRINGE LEAKED PRIOR TO ADMINISTRATION."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE LEAKED PROPOFOL PRIOR TO ADMINISTRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ICU HAD AN ISSUE WITH A 50ML BD PLASTIPAK SYRINGE... THEY NOTED IT WAS LEAKING... ANESTHETIST WAS ADMINISTERING PROPOFOL AND SYRINGE LEAKED PRIOR TO ADMINISTRATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550033 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2212060

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown