BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITX DRAINAGE BAG

    MDR report key: 24848768 · Received April 11, 2026

    Report

    Report Number
    1423507-2026-00060
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 13, 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: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE WAS NOT RETURNED. THE INVESTIGATION IS CURRENTLY UNDERWAY. G4: PMA/510K : K122422;K160437;K201155;K241946. D2: MEDICAL DEVICE TYPE: DWM; PNG. D.4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H.4. DEVICE MANUFACTURE DATE: UNKNOWN. 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.

    Additional Manufacturer Narrative · 0

    H11: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. IT WAS DETERMINED THAT THE IDENTIFIED DEFECTIVE COMPONENT IS A PURCHASED PART SUPPLIED BY AN EXTERNAL VENDOR. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. THE COMPLAINT HAS BEEN LOGGED IN THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE MONITORED THROUGH TRACKING, TRENDING, AND QUALITY DATA ANALYSIS FOR POTENTIAL FUTURE OCCURRENCES. G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H6: ANNEX G (COMPONENT CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS). 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 MARCH 11, 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. THE CUSTOMER STATED THAT THEY HAD HEARD OF SEVERAL OTHER INSTANCES OF BAGS LEAKING IN THE PAST MONTH. DURING FOLLOW UP, THE CUSTOMER INDICATED THEY WERE NOT AWARE OF ANY PRIOR LEAKAGE ISSUES BEING REPORTED TO BD AND DO NOT KNOW OF ANY COMPLAINTS HAVING BEEN OPENED FOR THOSE PAST INCIDENTS.

    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. THE CUSTOMER STATED THAT THEY HAD HEARD OF SEVERAL OTHER INSTANCES OF BAGS LEAKING IN THE PAST MONTH. DURING FOLLOW UP, THE CUSTOMER INDICATED THEY WERE NOT AWARE OF ANY PRIOR LEAKAGE ISSUES BEING REPORTED TO BD AND DO NOT KNOW OF ANY COMPLAINTS HAVING BEEN OPENED FOR THOSE PAST INCIDENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    119489 PERITX DRAINAGE BAG PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING PNG CAREFUSION, INC UNKNOWN 10885403222726

    Patients

    Seq Age Sex Outcome Treatment
    1