BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERITX PERITONEAL CATHETER & STARTER KIT

    MDR report key: 24765533 · Received April 2, 2026

    Report

    Report Number
    1423507-2026-00056
    Event Type
    Malfunction
    Date Received
    April 2, 2026
    Date of Event
    March 13, 2026
    Report Date
    March 25, 2026
    Manufacturer
    CAREFUSION, INC
    Product Code
    PNG
    UDI-DI
    10885403501838
    PMA / PMN Number
    SEE H.11.
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: THE PHYSICAL SAMPLE WAS NOT RECEIVED BY THE QUALITY TEAM; HOWEVER, THREE PHOTOS WERE PROVIDED FOR ANALYSIS. REVIEW OF THE PHOTOS IDENTIFIED THAT THE PRODUCT KIT TRAY WAS PACKAGED IN AN INCORRECT PRODUCT CARTON, CONFIRMING THE REPORTED ISSUE. THE ISSUE WAS ATTRIBUTED TO A MANUFACTURING-RELATED ERROR, AND A CORRECTIVE ACTION PROJECT WAS INITIATED TO FURTHER INVESTIGATE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, WHICH IDENTIFIED NO QUALITY ISSUES OR REJECTIONS ASSOCIATED WITH THE REPORTED EVENT. THE REVIEW CONFIRMED THAT ALL PROCEDURAL AND FUNCTIONAL RELEASE REQUIREMENTS WERE MET. HOWEVER, THE DHR REVIEW NOTED MULTIPLE COMPLAINTS ASSOCIATED WITH THE SAME LOT NUMBER. THIS COMPLAINT HAS BEEN ENTERED INTO THE COMPLAINT MANAGEMENT SYSTEM AND WILL BE TRACKED AND TRENDED FOR FUTURE OCCURRENCES AND FURTHER EVALUATED THROUGH THE QUALITY DATA ANALYSIS PROCESS. D4 (MEDICAL DEVICE EXPIRATION DATE), D4 (UNIQUE IDENTIFIER (UDI) #), H4: DEVICE MANUFACTURE DATE, G3 (DATE RECEIVED BY MANUFACTURER), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION). 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: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. THE DEVICE HAS NOT BEEN RETURNED; HOWEVER, PHOTOS WERE PROVIDED AND PHOTO REVIEW IS PENDING. THE INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. G4: PMA / 510(K)#: K201155; K241946. 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 THAT THE PERITX ITEM CAME PACKAGED IN A PLEURX BOX. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PERITX ITEM CAME PACKAGED IN A PLEURX BOX. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    822859 PERITX PERITONEAL CATHETER & STARTER KIT PERITONEAL, DRAINAGE CATHETER FOR REFRACTORY ASCITES, LONG-TERM INDWELLING PNG CAREFUSION, INC REKU0292 10885403501838

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown