BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 1ML SYRINGE LUER-LOK TIP

    MDR report key: 8693257 · Received June 12, 2019

    Report

    Report Number
    1213809-2019-00614
    Event Type
    Malfunction
    Date Received
    June 12, 2019
    Date of Event
    May 24, 2019
    Report Date
    July 3, 2019
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: TWO LOOSE 1ML SYRINGES AND ONE OPENED AND EMPTY BLISTER PACK FROM BATCH #9042756 (P/N 309628) WERE RECEIVED AND EVALUATED. THE SYRINGES WERE DISASSEMBLED, AND NO VISUAL DEFECTS WERE OBSERVED. THE BD 1ML HYPODERMIC SYRINGE IS A PISTON SYRINGE UNDER PRODUCT CODE FMF, AS DESCRIBED AT 21 C.F.R. § 880.5860, INTENDED FOR USE BY HEALTH CARE PROFESSIONALS FOR GENERAL PURPOSE FLUID ASPIRATION AND INJECTION. BD HAS ONLY TESTED AND VALIDATED THIS PRODUCT FOR USE IN ACCORDANCE WITH THE REFERENCED PRODUCT CODE. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. 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 FOREIGN MATTER OCCURRED WITH A BD 1ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, . "WHEN INJECT WITH 1ML LL SYRINGE,MIXED HISTOACRYL(GLUE)+LIPIODOL ULTRA SOLUTION(CONTRAST MEDIA)+5%DEXTROSE, HISTOACRYL BECOMES HARD IN 1ML LL SYRINGE." 3 OCCURRENCES REPORTED BEFORE USE.

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: 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 FOREIGN MATTER OCCURRED WITH A BD 1ML SYRINGE LUER-LOK¿ TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN INJECT WITH 1ML LL SYRINGE, MIXED HISTOACRYL (GLUE)+LIPIODOL ULTRA SOLUTION(CONTRAST MEDIA)+5%DEXTROSE, HISTOACRYL BECOMES HARD IN 1ML LL SYRINGE." 3 OCCURRENCES REPORTED BEFORE USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487043 BD 1ML SYRINGE LUER-LOK TIP SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 9042756 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other