BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS

    MDR report key: 22564085 · Received July 22, 2025

    Report

    Report Number
    22564085
    Event Type
    Malfunction
    Date Received
    July 22, 2025
    Date of Event
    July 12, 2025
    Report Date
    July 17, 2025
    Manufacturer
    BD SWITZERLAND SARL
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    2 SEPARATE EVENTS WHERE RNS WERE ATTEMPTING TO REMOVE BD MAXZERO NEEDLELESS CONNECTORS FROM PICC [PERIPHERALLY INSERTED CENTRAL CATHETER] LINE LUMENS AND WERE UNABLE TO DO SO BECAUSE THEY WERE SO TIGHTLY CONNECTED, THEY FEARED BREAKING THE LINE. THE CONNECTORS WERE ONLY ABLE TO BE REMOVED BY REPLACING THE PICC LINE CAP THAT IT WAS CONNECTED TO, WITH THE CONNECTOR STILL ATTACHED TO IT. STAFF DISCARDED THE PRODUCT AND WERE UNABLE TO PROVIDE PRODUCT IDENTIFIERS. 1) "WHEN TRYING TO CHANGE NEEDLELESS CONNECTOR ON PATIENTS PICC LINE, UNABLE TO REMOVE CONNECTOR FROM RED LUMEN ON PATIENT'S LINE. TRIED MULTIPLE TIMES, UNABLE TO REMOVE WITHOUT RISK OF DAMAGING LINE/LUMEN. NVAT [NURSING VASCULAR ACCESS TEAM] CAME TO BEDSIDE AND WAS ALSO UNABLE TO REMOVE CONNECTOR. NVAT COMPLETED ENTIRE PICC CAP CHANGE AND REMOVED CAP WITH THE CONNECTOR ATTACHED." 2) "UNABLE TO CHANGE CAP ON RED LUMEN OF CENTRAL LINE WITHOUT BREAKING LUMEN DUE TO NEEDLESS CONNECTOR. CONNECTOR TOO TIGHT. CAPS ARE DUE TO BE CHANGED [DATE REDACTED]. NVAT WAS REQUESTED TO COME ASSIST, AND ALSO UNABLE TO GET CONNECTOR OFF. THEY MANUALLY REMOVED THE CAPS FROM THE PICC LINE WITH CONNECTOR STILL ATTACHED AND REPLACED WITH NEW ONES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    803211 MAXPLUS SET, ADMINISTRATION, INTRAVASCULAR FPA BD SWITZERLAND SARL

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Male