BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXPLUS¿ NEEDLELESS CONNECTOR

    MDR report key: 12817957 · Received November 15, 2021

    Report

    Report Number
    9616066-2021-52423
    Event Type
    Malfunction
    Date Received
    November 15, 2021
    Date of Event
    October 2, 2021
    Report Date
    October 21, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K072542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) 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 MP1000. THE 510K NUMBER PROVIDED IS FOR THE DOMESTIC SIMILAR PRODUCT: K072542. INVESTIGATION SUMMARY: A MP1000 (B)(4) PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLES WERE FROM LOT 20085931. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE OCCLUSION WAS OBSERVED THREE TIMES AT THE START OF THE INFUSION AND ONCE A DAY INTO THE INFUSION. NO FURTHER INFORMATION WAS AVAILABLE INDICATING THE MAKE AND MODEL OF THE PRODUCT CONNECTED TO THE MAXPLUS. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 20085931 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. IN THIS INSTANCE, WITHOUT A SAMPLE, IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MP1000 (B)(4) PRODUCT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD MAXPLUS¿ NEEDLELESS CONNECTORS HAD FLOW ISSUES/BLOCKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE PATIENT WAS INDWELLED IN DEEP VEIN, AND THE FLUID DID NOT DROP AFTER THE NEEDLE-FREE CONNECTOR WAS REPLACED. AFTER VARIOUS PROBLEMS WERE SOLVED, THE NEEDLE-FREE CONNECTOR WAS REPLACED AGAIN. THE FLUID WAS SUCCESS, AND THE DRIPPING SPEED COULD REACH 100 MIN/DROP, AND THE FAULT WAS REMOVED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1712206 BD MAXPLUS¿ NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 20085931

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown