BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD TEXIUM¿ NEEDLE-FREE SYRINGE

    MDR report key: 15882526 · Received November 29, 2022

    Report

    Report Number
    9616066-2022-01819
    Event Type
    Malfunction
    Date Received
    November 29, 2022
    Date of Event
    November 2, 2022
    Report Date
    January 25, 2023
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FMF
    UDI-DI
    07613203018852
    PMA / PMN Number
    K071108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES, D10: RETURNED TO MANUFACTURER ON: 05-DEC-2022 H6: INVESTIGATION SUMMARY ONE MY8020-0006 SAMPLE WAS RECEIVED WITHOUT PACKAGING FOR INVESTIGATION; THE DEVICE WAS RECEIVED WITH MEDICATION INSIDE THE BARREL OF THE SYRINGE. THE FEEDBACK PROVIDED BY THE CUSTOMER SUGGESTS A BROWNISH CONTAMINANT WAS DETECTED NEAR THE MALE LUER OF THE SYRINGE. AS PART OF THE FEEDBACK THE CUSTOMER PROVIDED PHOTOGRAPHS OF THEIR EXPERIENCE; ANALYSIS OF THE PHOTOGRAPHS, IN ADDITION TO A VISUAL INSPECTION OF THE RETURNED SAMPLE CONFIRMED THE PRESENCE OF A BROWN CONTAMINANT IN THE THREAD OF THE MALE LUER OF THE SYRINGE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A DEFINITIVE ROOT CAUSE FOR THE OBSERVED CONTAMINATION COULD NOT BE DETERMINED, HOWEVER IT WAS LIKELY TO BE CAUSED BY DISCOLOURATION OF THE CHEMICALS USED TO BOND THE TEXIUM TO THE SYRINGE. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 92200302 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    2000E CHINA 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS MY8020. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT: K071108. 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 · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN THE BD TEXIUM¿ NEEDLE-FREE SYRINGE NOZZLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOLORATION IN THE 20 ML TEXIUM SYRINGE THE CUSTOMER DISCOVER A DISCOLORATION IN THE STERILE 20ML TEXIUM SYRINGE. SOMETHING BROWNISH CAN BE SEEN IN THE SYRINGE NOZZIE"

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BROWN FOREIGN MATTER WAS FOUND IN THE BD TEXIUM¿ NEEDLE-FREE SYRINGE NOZZLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DISCOLORATION IN THE 20 ML TEXIUM SYRINGE. THE CUSTOMER DISCOVER A DISCOLORATION IN THE STERILE 20ML TEXIUM SYRINGE. SOMETHING BROWNISH CAN BE SEEN IN THE SYRINGE NOZZIE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395345 BD TEXIUM¿ NEEDLE-FREE SYRINGE PISTON SYRINGE FMF SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 92200302 07613203018852

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown