BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 12484566 · Received September 16, 2021

    Report

    Report Number
    3003152976-2021-00602
    Event Type
    Malfunction
    Date Received
    September 16, 2021
    Date of Event
    August 20, 2021
    Report Date
    January 10, 2022
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-12-07. H6: INVESTIGATION SUMMARY SAMPLE AND PHOTO RECEIVED FOR INVESTIGATION, UPON VISUAL INSPECTION, SAMPLE PROVIDED SHOWS LEAKAGE PAST THE STOPPER. THE STOPPER IS CORRECTLY ASSEMBLED TO THE PLUNGER AND NO DAMAGE CAN BE IDENTIFIED IN THE BARREL OF THE SYRINGE THAT COULD LEAD TO THE LEAKAGE PAST THE STOPPER EXPERIENCED BY CUSTOMER. FUNCTIONAL TESTING WAS PERFORMED, THE SYRINGE WAS DISASSEMBLED AND NO DAMAGE CAN BE OBSERVED IN THE PLUNGER. LEAKAGE TEST WAS PERFORMED, NO LEAK OBSERVED. IN THE PICTURES IT CAN BE SEEN THE SAMPLE FILLED WITH PROPOFOL AND WITH VISIBLE LEAKAGE PAST THE STOPPER. SINCE NO MANUFACTURING DEFECT CAN BE OBSERVED IN VISUAL INSPECTION OF THE SAMPLE EVALUATED AND NO LEAKAGE OCCURRED, THE ROOT CAUSE FOR LEAKAGE OF THE ALLEGED DEFECT CANNOT BE DETERMINED WITH EVIDENCE. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2012069, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED 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. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THE STOPPER WAS DEFECTIVE/DEFORMED (E PC AND EMERALD SYRINGE ONLY) AND LEAKAGE PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE INFUSION OF PROPOFOL WAS NOTED TO BE LEAKING OUT THE BACK OF THE SYRINGE, IN SYRINGE DRIVER AND ONTO THE FLOOR. LINE OBSERVED TO BE ENTRAINING AIR ALSO, WITH MEDICATION STILL IN PATIENT END OF LINE."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED WHEN USING THE BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE THE STOPPER WAS DEFECTIVE/DEFORMED (E PC AND EMERALD SYRINGE ONLY) AND LEAKAGE PAST THE STOPPER/PLUNGER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE INFUSION OF PROPOFOL WAS NOTED TO BE LEAKING OUT THE BACK OF THE SYRINGE, IN SYRINGE DRIVER AND ONTO THE FLOOR. LINE OBSERVED TO BE ENTRAINING AIR ALSO, WITH MEDICATION STILL IN PATIENT END OF LINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378842 BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2012069

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown