BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD¿ LUER SLIP TIP SYRINGE

    MDR report key: 14980900 · Received July 11, 2022

    Report

    Report Number
    1213809-2022-00386
    Event Type
    Malfunction
    Date Received
    July 11, 2022
    Date of Event
    June 13, 2022
    Report Date
    June 25, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K980580
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    TWO PHOTOS WERE RECEIVED AND EVALUATED. THROUGH VISUAL INSPECTION, IT IS OBSERVED THAT THE SYRINGE WAS MISSING THE ENTIRETY OF ITS PRINTED SCALE AND THE BARREL APPEARED TO BE PINCHED ABOUT AN INCH UP FROM THE ROOF OF THE BARREL. THE OBSERVED CONDITIONS WERE NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE PINCHED BARREL AND MISSING PRINT DEFECTS IS ASSOCIATED WITH THE MARKING PROCESS. IT IS LIKELY A BARREL WAS PINCHED ENTERING THE MARKER AND WAS INADVERTENTLY PROCESSED THROUGH RESULTING IN THE MISSING PRINT CONDITION. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. BATCH 1061961 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1061961. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WERE NO SCALE MARKINGS ON THE BD¿ LUER SLIP TIP SYRINGE BARREL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT SYRINGE IN THE PACK WAS WARPED OR MELTED WITHOUT NUMBERS ON IT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396059 BD¿ LUER SLIP TIP SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1061961

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown