BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 8846317 · Received July 31, 2019

    Report

    Report Number
    3003152976-2019-00494
    Event Type
    Malfunction
    Date Received
    July 31, 2019
    Date of Event
    July 15, 2019
    Report Date
    September 16, 2019
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 1905236, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TEN RETAINED SAMPLES OF LOT 1905236 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. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THERE WAS LEAKAGE PAST THE STOPPER WITH BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2) ADDITIONALLY, WE HAVE NOTICED A FAULT TODAY WITH ONE SYRINGE OF THE SAME TYPE FROM A DIFFERENT BATCH. FROM INITIAL COMPLAINT: FAILURE OF SYRINGE. UPON USE IN THE ASEPTIC DEPARTMENT, THE BROTH LIQUID WAS LEAKING INTO THE PLUNGER.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 THAT DURING USE THERE WAS LEAKAGE PAST THE STOPPER WITH BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2 OF 2) ADDITIONALLY, WE HAVE NOTICED A FAULT TODAY WITH ONE SYRINGE OF THE SAME TYPE FROM A DIFFERENT BATCH. FROM INITIAL COMPLAINT: FAILURE OF SYRINGE. UPON USE IN THE ASEPTIC DEPARTMENT, THE BROTH LIQUID WAS LEAKING INTO THE PLUNGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640613 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1905236

    Patients

    Seq Age Sex Outcome Treatment
    1 Other