BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE

    MDR report key: 10182112 · Received June 22, 2020

    Report

    Report Number
    3003152976-2020-00263
    Event Type
    Malfunction
    Date Received
    June 22, 2020
    Date of Event
    June 1, 2020
    Report Date
    August 7, 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

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 8/5/2020. H.6. INVESTIGATION: SIX UNUSED SAMPLES WERE RETURNED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, IT COULD NOT BE OBSERVED THAT THE SCALE WAS INCORRECTLY PLACED ON ANY OF THE SYRINGES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 1912254, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS 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. DURING THE BARREL PRINTING PROCESS, OPERATORS PERIODICALLY VERIFY THE VOLUME ACCURACY WITH A PASS/NON PASS GAUGE. THE RETURNED SAMPLES WERE EVALUATED USING THE SAME METHOD AND WERE FOUND TO BE WITHIN REQUIRED TOLERANCE. SCALE PRECISION AND DIED SPACE IS ALSO INSPECTED DURING MANUFACTURING AND ALL SIX SAMPLES WERE FOUND TO BE WITHIN SPECIFICATION. BASED ON THE AVAILABLE INFORMATION, WE CANNOT IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PLASTIPAK¿ 50ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE HAS INCORRECT MARKINGS HENCE ADMINISTERING DRUGS IN INCORRECT MEASUREMENT.

    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 THE BD PLASTIPAK¿ 50 ML CONCENTRIC LUER LOCK SYRINGE EXPERIENCED SCALE MARKING ISSUES WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SYRINGE HAS INCORRECT MARKINGS HENCE ADMINISTERING DRUGS IN INCORRECT MEASUREMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641522 BD PLASTIPAK 50ML CONCENTRIC LUER LOCK SYRINGE PISTON SYRINGE FMF BECTON DICKINSON, S.A. 1909214

    Patients

    Seq Age Sex Outcome Treatment
    1 Other