BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8608598 · Received May 14, 2019

    Report

    Report Number
    3003152976-2019-00320
    Event Type
    Malfunction
    Date Received
    May 14, 2019
    Date of Event
    April 26, 2019
    Report Date
    July 8, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    UDI-DI
    00382903249107
    PMA / PMN Number
    K024112
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: 15 USED SAMPLES AND TWO VIDEOS WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. DUE TO THE SAMPLES BEING CONTAMINATED WITH TOXIC DRUGS, WE WERE NOT ABLE TO CONDUCT ANY INVESTIGATION OR EVALUATION ON THE PRODUCT. REVIEW OF THE VIDEO SHOWED LEAKAGE PAST THE STOPPER RIBS WHEN THE PLUNGER IS MOVED FORWARD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1810261 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1810261 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LIQUID LEAKAGE."

    Additional Manufacturer Narrative · 1

    (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: 16 USED SAMPLES AND TWO VIDEOS WERE RETURNED TO OUR QUALITY ENGINEER FOR INVESTIGATION. THROUGH VISUAL INSPECTION, NO DAMAGE WAS OBSERVED IN ANY OF THE SAMPLES. THE PRODUCT WAS DISASSEMBLED, NO DAMAGE OR MOLDING DEFECT WAS IDENTIFIED IN THE PLUNGER ROD THAT COULD HAVE CONTRIBUTED TO THIS INCIDENT. REVIEW OF THE VIDEO SHOWED LEAKAGE PAST THE STOPPER RIBS WHEN THE PLUNGER IS MOVED FORWARD. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1810261 , NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1810261 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LIQUID LEAKAGE."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT LEAKAGE OCCURRED WITH A BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "LIQUID LEAKAGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403676 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1810261 00382903249107

    Patients

    Seq Age Sex Outcome Treatment
    1 Other