BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITX DRAINAGE BAG

    MDR report key: 24779862 · Received April 3, 2026

    Report

    Report Number
    1423507-2026-00058
    Event Type
    Malfunction
    Date Received
    April 3, 2026
    Date of Event
    March 11, 2026
    Report Date
    May 11, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    PNG
    UDI-DI
    10885403222726
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, 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. 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 : K122422;K160437;K201155;K241946. 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 THE CUSTOMER ON (B)(6) 2026, THAT THE PERITX DRAINAGE BAG WAS LEAKING DURING USE, DESPITE CONFIRMATION THAT BOTH THE DRAINAGE END AND THE CLAMP WERE SECURELY CLOSED. DURING FOLLOW UP INFORMATION RECEIVED ON MARCH 29, 2026, IT WAS FURTHER REPORTED THAT THERE WAS NO DIRECT PATIENT OR HEALTHCARE PROVIDER INJURY. THE SOURCE OF THE LEAK COULD NOT BE CLEARLY IDENTIFIED. THE REPORTER STATED THAT AFTER ENSURING THE DRAINAGE CAP WAS TWISTED CLOSED, APPROXIMATELY 1000 ML OF FLUID WAS COLLECTED, THE DEVICE WAS DISCONNECTED FROM THE PATIENT, THE ROLLER CLAMP WAS CLOSED, AND THE PLEURX BAG WAS DISCARDED INTO A GARBAGE BAG PLACED ON THE FLOOR. SHORTLY THEREAFTER, AN ESTIMATED 500 ML OF FLUID LEAKED ONTO THE FLOOR. DUE TO THE VOLUME OF FLUID AROUND THE BAG, THE EXACT SOURCE OF THE LEAK COULD NOT BE VISUALLY DETERMINED. AS THE DRAINAGE CAP AND ROLLER CLAMP HAD BEEN CONFIRMED CLOSED, THE LEAK WAS SUSPECTED TO HAVE ORIGINATED FROM THE BAG ITSELF OR POSSIBLY FROM THE CONNECTION BETWEEN THE BAG AND THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187914 PERITX DRAINAGE BAG PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING PNG CAREFUSION, INC 0001642276 10885403222726

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown