BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXPLUS¿ NEEDLELESS CONNECTOR

    MDR report key: 15676780 · Received October 26, 2022

    Report

    Report Number
    9616066-2022-01621
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    July 14, 2022
    Report Date
    October 24, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403238338
    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

    MP1000-C 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 MP1000-C. THE 510K NUMBER PROVIDED IN IS FOR THE DOMESTIC SIMILAR PRODUCT: K072542. INVESTIGATION SUMMARY: A MP1000-C CHINA PRODUCT WAS NOT AVAILABLE; HOWEVER, THE CUSTOMER INDICATED THE COMPLAINT SAMPLE IS FROM LOT 22016267. THE FEEDBACK PROVIDED BY THE CUSTOMER INDICATES LEAKAGE WAS DETECTED FROM THE MAXPLUS COMPONENT IN CONNECTION WITH AN UNKNOWN PRODUCT. NO FURTHER INFORMATION WAS AVAILABLE TO ASSIST THE INVESTIGATION IN THIS INSTANCE. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 22016267 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 IN THIS INSTANCE. WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LEAKAGE. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT THIS IS A RARE OCCURRENCE WITH A SMALL NUMBER OF SIMILAR REPORTS AGAINST THE MAXPLUS COMPONENT IN THE PAST 12 MONTHS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FLUID LEAKED FROM THE BD MAXPLUS NEEDLELESS CONNECTOR CONNECTION TO THE INFUSION SET DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE FLUID INFUSED AT THE INDWELLING NEEDLE OF THE RIGHT INTERNAL JUGULAR VEIN SLOWLY OVERFLOWED FROM THE CONNECTION BETWEEN THE TRANSPARENT NEEDLE FREE CONNECTOR AND THE INFUSION SET INTERFACE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2761703 BD MAXPLUS¿ NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22016267 10885403238338

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown