BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD MAXPLUS¿ POSITIVE PRESSURE CONNECTOR

    MDR report key: 15353311 · Received September 2, 2022

    Report

    Report Number
    9616066-2022-01283
    Event Type
    Malfunction
    Date Received
    September 2, 2022
    Date of Event
    August 12, 2022
    Report Date
    November 2, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    10885403223228
    PMA / PMN Number
    K072542
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MP1000-C 510K: THIS IS AN INTERNATIONAL CODE - THE MODEL#/CATALOG# IDENTIFIED IN 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 IN SECTION G5 IS FOR THE DOMESTIC SIMILAR PRODUCT: K072542. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A VIDEO WAS SENT BY CUSTOMER AND ANALYZED BY OUR QUALITY TEAM. THE LEAK HAS BEEN VERIFIED AND IS CLEARLY PRESENT IN THE PROVIDED VIDEO. THE ROOT CAUSE OF THIS FAILURE IS UNKNOWN THOUGH, WITHOUT A PHYSICAL SAMPLE FOR INVESTIGATION. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE A LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    CORRECTION: H1: TYPE OF REPORTABLE EVENTS: MALFUNCTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXPLUS¿ POSITIVE PRESSURE CONNECTOR WAS LOOSE AND LEAKED FROM THE Y-SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CUSTOMER FLUSHED THE MAIN PORT OF THE HUBER NEEDLE THEY OBSERVED "SPRAYING/LEAKING" FROM THE Y-SITE- WHERE THE MAX CONNECTOR IS CONNECTED TO THE SWABCAP."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXPLUS¿ POSITIVE PRESSURE CONNECTOR WAS LOOSE AND LEAKED FROM THE Y-SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CUSTOMER FLUSHED THE MAIN PORT OF THE HUBER NEEDLE THEY OBSERVED "SPRAYING/LEAKING" FROM THE Y-SITE- WHERE THE MAX CONNECTOR IS CONNECTED TO THE SWABCAP".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD MAXPLUS¿ POSITIVE PRESSURE CONNECTOR WAS LOOSE AND LEAKED FROM THE Y-SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN CUSTOMER FLUSHED THE MAIN PORT OF THE HUBER NEEDLE THEY OBSERVED "SPRAYING/LEAKING" FROM THE Y-SITE- WHERE THE MAX CONNECTOR IS CONNECTED TO THE SWABCAP".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2561516 BD MAXPLUS¿ POSITIVE PRESSURE CONNECTOR INTRAVASCULAR CATHETER FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. UNKNOWN 10885403223228

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown