BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE LUER-LOK TIP

    MDR report key: 8629953 · Received May 21, 2019

    Report

    Report Number
    1213809-2019-00556
    Event Type
    Malfunction
    Date Received
    May 21, 2019
    Date of Event
    May 3, 2019
    Report Date
    May 31, 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
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: TWO PHOTOS OF A LOOSE 1ML SYRINGE WERE RECEIVED AND EVALUATED. ONE PHOTO DISPLAYED THE SYRINGE NEXT TO A GLASS MEDICATION BOTTLE AND THE MEDICATION PACKAGING. ONE PHOTO SHOWED A CLOSE-UP IMAGE OF THE SYRINGE WITH 0.1ML OF FLUID AND A LOOSE SMALL WHITE FOREIGN MATTER PARTICLE IN THE FLUID PATH. IT APPEARS TO BE THE PLASTIC TIP OF A PLUNGER ROD FROM A DIFFERENT SYRINGE AND IS LARGER THAN LEVEL 2 IN SIZE, WHICH IS REJECTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. 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

    MATERIAL NO.: 309628 BATCH NO.: 5075578. IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS A WHITE PRECIPITATE THAT FORMED AFTER THE PRODUCT WAS DRAWN UP WITH THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER EMAIL: THE REPORTER STATED A 1MM BY 3MM WHITE PRECIPITANT THAT FORMED AFTER THE PRODUCT WAS DRAWN UP WITH THE SUPPLIED FILTER NEEDLE AND SYRINGE. THE ISOLATED FOREIGN MATTER WAS OBSERVED TO BE WHITE IN COLOR WITH DIMENSIONS OF APPROXIMATELY 5 MM IN LENGTH AND 3 MM IN WIDTH. IDENTIFICATION TESTING WAS PERFORMED ON THE FOREIGN MATTER ISOLATED FROM THE RETURNED SYRINGE USING THE ATTENUATED TOTAL REFLECTION (ATR) MODE OF THE LUMOS FOURIER TRANSFORM-INFRARED (FT-IR) SPECTROMETER (BRUKER). A SIMILARITY SEARCH OF THE OBTAINED FOREIGN MATTER SPECTRUM WAS PERFORMED TO COMPARE THE SPECTRUM WITH THE OPUS LIBRARY SPECTRA. THE BEST MATCHES OBTAINED WERE HIGHLY SOFTENED FOAM SYMPATEX WHITE AND DIISODECYL PHTHALATE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    MATERIAL NO.: 309628, BATCH NO.: 5075578. IT WAS REPORTED THAT DURING USE OF THE BD SYRINGE LUER-LOK¿ TIP THERE WAS A WHITE PRECIPITATE THAT FORMED AFTER THE PRODUCT WAS DRAWN UP WITH THE SYRINGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PER EMAIL: THE REPORTER STATED A 1MM BY 3MM WHITE PRECIPITANT THAT FORMED AFTER THE PRODUCT WAS DRAWN UP WITH THE SUPPLIED FILTER NEEDLE AND SYRINGE. THE ISOLATED FOREIGN MATTER WAS OBSERVED TO BE WHITE IN COLOR WITH DIMENSIONS OF APPROXIMATELY 5 MM IN LENGTH AND 3 MM IN WIDTH. IDENTIFICATION TESTING WAS PERFORMED ON THE FOREIGN MATTER ISOLATED FROM THE RETURNED SYRINGE USING THE ATTENUATED TOTAL REFLECTION (ATR) MODE OF THE LUMOS FOURIER TRANSFORM-INFRARED (FT-IR) SPECTROMETER (BRUKER). A SIMILARITY SEARCH OF THE OBTAINED FOREIGN MATTER SPECTRUM WAS PERFORMED TO COMPARE THE SPECTRUM WITH THE OPUS LIBRARY SPECTRA. THE BEST MATCHES OBTAINED WERE HIGHLY SOFTENED FOAM SYMPATEX WHITE AND DIISODECYL PHTHALATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    423558 BD SYRINGE LUER-LOK TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5075578 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 Other