BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX LOCKABLE DRAINAGE LINE SET

    MDR report key: 24771985 · Received April 2, 2026

    Report

    Report Number
    1423507-2026-00057
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 23, 2026
    Report Date
    March 25, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403174872
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: A LOT NUMBER WAS PROVIDED; THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE INVESTIGATION IS CURRENTLY UNDERWAY. PHOTOS WERE PROVIDED AND REVIEW IS CURRENTLY PENDING. H3 (DEVICE EVAL BY MANUFACTURER) A DEVICE HAS NOT BEEN RETURNED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G4: PMA/510K: K141965;K160437;K160450. D2: MEDICAL DEVICE TYPE: DWM;PNG. SECTION A THROUGH F ¿ THE INFORMATION PROVIDE BY BD REPRESENTS ALL THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT/REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE CARE TEAM REJECTED A PLEURX LOCKABLE DRAINAGE LINE SET BECAUSE THEY OBSERVED A PIECE OF WASTE INSIDE THE PRODUCT, THAT APPEARS TO BE A PIECE OF CARDBOARD. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829503 PLEURX LOCKABLE DRAINAGE LINE SET APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001448627 10885403174872

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown