BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 10ML LL BNS

    MDR report key: 10027108 · Received May 5, 2020

    Report

    Report Number
    1213809-2020-00287
    Event Type
    Malfunction
    Date Received
    May 5, 2020
    Date of Event
    April 15, 2020
    Report Date
    April 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION SUMMARY: THIS IS THE 1ST RELATED COMPLAINT FOR SCALE MARKING ISSUE ON THE PROVIDED LOT NUMBER 9081846. RELEASE DATE: 4/10/2019. RELEASED QUANTITY WAS (B)(4). ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 9081846 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ONE PHOTO DISPLAYING SIX LOOSE 10ML SYRINGES WERE RECEIVED AND EVALUATED. IT WAS OBSERVED FIVE OF THE SYRINGES HAD SOME DEGREE OF MISSING PRINT. THREE OF THE SYRINGES WERE MISSING PRINT NEAR THE TOP OF THE SCALE AND LOGO AREA AND PORTIONS OF GRAD LINES MISSING NEAR THE MIDDLE OF THE SCALE. THE THREE SYRINGES WERE MISSING 50% OR MORE OF ANY ONE ITEM, WHICH WERE REJECTABLE PER PRODUCT SPECIFICATION. TWO OF THE SYRINGES HAD A SMALL SCRATCH ACROSS THE SCALE WITH AN ACCEPTABLE AMOUNT OF MISSING PRINT. ONE SYRINGE HAD A FEW INK DOTS BETWEEN THE 4ML AND 5ML MARKING WITH ALL DOTS SMALLER THAN LEVEL 3 IN SIZE, WHICH WERE ACCEPTABLE PER PRODUCT SPECIFICATION. INVESTIGATION CONCLUSION: THE AQL FOR MISSING PRINT IS 0.25%. THE DEFECTIVE RATE IDENTIFIED IS 3 OUT OF (B)(4), WHICH IS (B)(4). NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 9081846 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. ROOT CAUSE DESCRIPTION: POTENTIAL ROOT CAUSE FOR THE MISSING PRINT AND INK DOT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SYRINGE 10ML LL BNS HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN ACCORDANCE WITH THE PROCEDURE, I REPORT THE DEFECTS FOUND AT THE END OF A BATCH. IT CONCERNS 6 PIECES OF 10ML SYRINGES. ARTICLE NUMBER: 301029. BATCH: 9081846. BATCH SIZE: 15 BOXES. DEFECT: INCOMPLETE SCALE. STAXS COMPLAINT REFERENCE: (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487010 SYRINGE 10ML LL BNS PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9081846

    Patients

    Seq Age Sex Outcome Treatment
    1 Other