BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK SYRINGE WITH NEEDLE

    MDR report key: 10242726 · Received July 7, 2020

    Report

    Report Number
    3002682307-2020-00214
    Event Type
    Malfunction
    Date Received
    July 7, 2020
    Date of Event
    June 17, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 9/15/2020. H.6. INVESTIGATION: ONE PHOTO AND ONE PHYSICAL SAMPLE WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, LIQUID WAS OBSERVED PAST THE STOPPER RIBS. THERE IS NO DAMAGE OR MOLDING DEFECT IDENTIFIED ON THE PRODUCT THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAK AND THE STOPPER WAS VERIFIED TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1912207, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1912207 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, LIQUID WAS OBSERVED PAST THE STOPPER RIBS. THERE IS NO VISIBLE DAMAGE OR MOLDING DEFECT IDENTIFIED THAT COULD HAVE CONTRIBUTED TO THE REPORTED LEAK AND THE STOPPER APPEARS TO BE PROPERLY ASSEMBLED ONTO THE PLUNGER. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1912207, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1912207 WERE USED TO CONDUCT A LEAKAGE TEST. THE PRODUCT WAS VISUALLY INSPECTED, NO DEFECTS OR DAMAGE WAS NOTED, AND NO LEAK WAS IDENTIFIED. 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 AVAILABLE INFORMATION WE ARE NOT ABLE TO DETERMINE A ROOT CAUSE AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH NEEDLE FILLED WITH PROPOFOL LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PERFUSION SYRINGES WERE FILLED WITH PROPOFOL AND ARE LEAKING OR RUNNING BACK"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH NEEDLE FILLED WITH PROPOFOL LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PERFUSION SYRINGES WERE FILLED WITH PROPOFOL AND ARE LEAKING OR RUNNING BACK".

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD LUER-LOK¿ SYRINGE WITH NEEDLE FILLED WITH PROPOFOL LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "PERFUSION SYRINGES WERE FILLED WITH PROPOFOL AND ARE LEAKING OR RUNNING BACK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    707065 BD LUER-LOK SYRINGE WITH NEEDLE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1912207

    Patients

    Seq Age Sex Outcome Treatment
    1 Other