BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10423690 · Received August 18, 2020

    Report

    Report Number
    3003152976-2020-00379
    Event Type
    Malfunction
    Date Received
    August 18, 2020
    Date of Event
    July 30, 2020
    Report Date
    October 2, 2020
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE CONDITION OF THE REPORTED PRODUCT WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE REPORTED LOT 2001270, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. TWO RETAINED SAMPLES OF LOT 2001270 WERE USED FOR ADDITIONAL EVALUATION. THE PRODUCT WAS INSPECTED AND NO FOREIGN MATTER WAS OBSERVED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE MANUFACTURING PROCESS AT THIS TIME. QUALITY PROJECT#1690 WAS INITIATED TO REDUCE ANY FOREIGN MATTER WITHIN OUR PRODUCTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER "ORANGE/WHITE/GRAY PARTICLES" WERE DISCOVERED IN SYRINGE PRIOR TO USE WITH 100 BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ORANGE/WHITE/GREY PARTICLES BEING PRESENT IN SYRINGE.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOREIGN MATTER "ORANGE/WHITE/GRAY PARTICLES" WERE DISCOVERED IN SYRINGE PRIOR TO USE WITH 100 BD PLASTIPAK¿ 50 ML CONCENTRIC LUER LOCK SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ORANGE/WHITE/GREY PARTICLES BEING PRESENT IN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883040 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 2001270

    Patients

    Seq Age Sex Outcome Treatment
    1 Other