BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP

    MDR report key: 11921079 · Received June 2, 2021

    Report

    Report Number
    1213809-2021-00388
    Event Type
    Malfunction
    Date Received
    June 2, 2021
    Date of Event
    April 27, 2021
    Report Date
    June 3, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K980987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: ONE LOOSE 3ML SYRINGE AND ONE OPENED BLISTER PACK FROM BATCH 1012906 (P/N 309657) WERE RECEIVED AND EVALUATED. IT WAS OBSERVED MOST OF THE PRINTED SCALE WAS MISSING WITH NO LEGIBLE NUMERALS OR COMPLETE GRAD LINES. THE POOR PRINT WAS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE MISSING PRINT DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. NO CORRECTIVE ACTIONS ARE NECESSARY BASED ON THE DEFECTIVE RATE IDENTIFIED. BATCH 1012906 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE SCALE MARKINGS ON THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WERE ILLEGIBLE AND/OR PARTIALLY MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUID MEASUREMENT LINES PARTIALLY FADED AND SOME MEASUREMENT LINES MISSING. IT APPEARS THAT THE MEASUREMENTS HAVE RUBBED OFF; HOWEVER, THE SYRINGE IS NEW, UNUSED AND NOT EXPIRED."

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SCALE MARKINGS ON THE BD LUER-LOK¿ DISPOSABLE SYRINGE WITH BD LUER-LOK¿ TIP WERE ILLEGIBLE AND/OR PARTIALLY MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUID MEASUREMENT LINES PARTIALLY FADED AND SOME MEASUREMENT LINES MISSING. IT APPEARS THAT THE MEASUREMENTS HAVE RUBBED OFF; HOWEVER, THE SYRINGE IS NEW, UNUSED AND NOT EXPIRED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816666 BD LUER-LOK DISPOSABLE SYRINGE WITH BD LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309657 1012906 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1