BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Q-SYTE

    MDR report key: 22199675 · Received June 12, 2025

    Report

    Report Number
    1710034-2025-01004
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 18, 2025
    Report Date
    June 25, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FPA
    UDI-DI
    00382903851003
    PMA / PMN Number
    K013621
    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 RESULTS: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 385100 AND LOT NUMBER 4213935. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    DESCRIPTION: ON (B)(6) 2025, THE PICC WAS CHANGED, AND AT THE SAME TIME, THE SPLIT DIAPHRAGM NEEDLELESS CLOSED INFUSION CONNECTOR AT THE END OF THE CATHETER WAS REPLACED, CONNECTING 5 STICKS OF NICLOSAMIDE + 42.5 ML OF SALINE TO BE PUMPED IN AT 5 ML/H. IT WAS FOUND THAT THE CONNECTOR WAS CRACKED IN THE MORNING OF MAY 18, AND THE WHOLE TIME BLOOD WAS RETURNED IN THE PICC CATHETER, AND GAUZE WRAPPED AROUND THE CONNECTOR WAS SOAKED, RESULTING IN THE FAILURE TO ENSURE THAT THE MEDICATION COULD BE PUMPED IN PROPERLY, AND THE EXISTENCE OF A BLOCKED LINE THAT COULD NOT BE RE-CIRCULATED. RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635444 Q-SYTE SET, ADMINISTRATION, INTRAVASCULAR FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 4213935 00382903851003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown