BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 1ML S/T BNS

    MDR report key: 10075252 · Received May 20, 2020

    Report

    Report Number
    1213809-2020-00324
    Event Type
    Malfunction
    Date Received
    May 20, 2020
    Date of Event
    March 13, 2020
    Report Date
    May 28, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY TEN LOOSE 1ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED ON ALL THE SYRINGES THERE WAS FADED PRINT ON THE NUMBERS STARTING AT THE ¿9¿ AND EXTENDING TOWARDS THE TIP. THE AMOUNT OF NUMBERS WITH FADED PRINT VARIED FROM TWO TO EIGHT. NONE OF THE NUMBERS ON ANY OF THE SYRINGES WERE MISSING MORE THAN 50% OF ANY ONE ITEM WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. SEVEN OF THE TEN SYRINGES HAD A SIGNIFICANTLY ROLLED SCALE TO THE POINT THE SCALE MARKING WERE ON THE SIDE OF THE BARREL, UNDER THE FLANGE, WHICH WAS REJECTABLE PER PRODUCT SPECIFICATION. A POTENTIAL ROOT CAUSE FOR THE ROLLED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THE AQL FOR ROLLED SCALE IS 0.25%. THE DEFECTIVE RATE IDENTIFIED IS 7 OUT OF 792,000, WHICH IS 0.0009%. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 792,000 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF SCALE MARKING ISSUE WITH LOT #9081593 REGARDING ITEM #301025. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS WERE INCOMPLETE OR MISSING WITH AN BD SYRINGE 1ML S/T BNS. THIS OCCURRED ON 447 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SCALE MARKINGS ON SYRINGES ARE EITHER MISSING, SMUDGED OR INCOMPLETE.

    Additional Manufacturer Narrative · 1

    A SAMPLE IS AVAILABLE FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKINGS WERE INCOMPLETE OR MISSING WITH AN BD SYRINGE 1ML S/T BNS. THIS OCCURRED ON 447 SEPARATE OCCASIONS PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT SCALE MARKINGS ON SYRINGES ARE EITHER MISSING, SMUDGED OR INCOMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537462 BD SYRINGE 1ML S/T BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9081593

    Patients

    Seq Age Sex Outcome Treatment
    1 Other