BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXPLUS NEEDLELESS CONNECTOR

    MDR report key: 14564876 · Received June 1, 2022

    Report

    Report Number
    9616066-2022-00670
    Event Type
    Malfunction
    Date Received
    June 1, 2022
    Date of Event
    April 10, 2022
    Report Date
    May 9, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: AN MP1000 CHINA PRODUCT WAS NOT AVAILABLE FOR INVESTIGATION; HOWEVER THE CUSTOMER CONFIRMED THAT THE COMPLAINT SAMPLE WAS FROM LOT 21015952. FURTHER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT THE PRODUCT WAS CONNECTED TO A SIPOTREIS BIOTECHNOLOGY CO., LTD SET WHEN THE LEAKAGE WAS OBSERVED. THE CUSTOMER ALSO REPORTS THAT NO DAMAGE WAS OBSERVED TO THE AFFECTED PRODUCT. THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE MANUFACTURING SITE FOR INVESTIGATION. A REVIEW OF THE PRODUCTION RECORDS FOR LOT 21015952 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. IN THIS INSTANCE THERE WAS NOT ENOUGH INFORMATION TO POSITIVELY LINK THIS FEEDBACK TO A SPECIFIC FAILURE MODE; HOWEVER, 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 THE BD MAXPLUS NEEDLELESS CONNECTOR EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: THE POSITIVE PRESSURE CONNECTOR WAS FOUND TO BE LEAKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1460753 BD MAXPLUS NEEDLELESS CONNECTOR INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 21015952

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown