BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE NEEDLE-FREE VALVE

    MDR report key: 15959698 · Received December 12, 2022

    Report

    Report Number
    9616066-2022-01923
    Event Type
    Malfunction
    Date Received
    December 12, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 19, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403238345
    PMA / PMN Number
    K061285
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    2000E CHINA 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IN SECTION D4 IS A CAREFUSION PRODUCT WHICH IS SAME OR SIMILAR TO A DEVICE THAT IS APPROVED FOR SALE DOMESTICALLY. THE DOMESTIC SIMILAR LIST NUMBER IS 2000E. THE 510K NUMBER PROVIDED IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT: K061285. 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

    H6: INVESTIGATION SUMMARY A 2000E CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 22035663. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT BLACK FOREIGN MATTER WAS FOUND WITHIN THE PACKAGING OF THE 2000E CHINA PRODUCT, HOWEVER NO FURTHER INFORMATION WAS AVAILABLE RELATING TO THE NATURE OF THE CONTAMINANT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 22035663 DID NOT IDENTIFY ANY IN-PROCESS TESTING FAILURES OR QUALITY DEVIATIONS WHICH MAY HAVE RESULTED IN A REPORT OF THIS NATURE. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE HAS BLACK PARTICLES INSIDE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2022, WHEN THE NURSE IN THE GENERAL SURGERY WARD TOOK OUT THE INFUSION CONNECTOR, HE FOUND THAT THERE WERE BLACK IMPURITIES IN THE PACKAGE, WHICH DID NOT MEET THE REQUIREMENTS FOR STERILE USE, AND IMMEDIATELY REPLACED IT WITH A NEW INFUSION CONNECTOR OF THE SAME BATCH. THE INFUSION CONNECTOR WAS NOT USED ON THE PATIENT AND CAUSED NO HARM. ONLY ONE CASE OF THIS BATCH HAS BEEN FOUND SO FAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD ALARIS SMARTSITE NEEDLE-FREE VALVE HAS BLACK PARTICLES INSIDE PACKAGING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2022, WHEN THE NURSE IN THE GENERAL SURGERY WARD TOOK OUT THE INFUSION CONNECTOR, HE FOUND THAT THERE WERE BLACK IMPURITIES IN THE PACKAGE, WHICH DID NOT MEET THE REQUIREMENTS FOR STERILE USE, AND IMMEDIATELY REPLACED IT WITH A NEW INFUSION CONNECTOR OF THE SAME BATCH. THE INFUSION CONNECTOR WAS NOT USED ON THE PATIENT AND CAUSED NO HARM. ONLY ONE CASE OF THIS BATCH HAS BEEN FOUND SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2146205 BD ALARIS SMARTSITE NEEDLE-FREE VALVE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22035663 10885403238345

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown