BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX

    MDR report key: 22124616 · Received June 2, 2025

    Report

    Report Number
    1625685-2025-00049
    Event Type
    Malfunction
    Date Received
    June 2, 2025
    Date of Event
    May 6, 2025
    Report Date
    July 22, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403075988
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS HAS NOT BEEN PERFORMED. THE DEVICE IS NOT AVAILABLE FOR RETURN. THE INVESTIGATION IS CURRENTLY UNDERWAY. H11: 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. HOWEVER, THE INVESTIGATION WAS CONFIRMED AS USE RELATED BASED ON THE PROVIDED INFORMATION STATING THE TUBING WAS PROBABLY CUT WITH THE SCISSORS WHEN THE BANDAGE WAS BEING REMOVED. THE ROOT CAUSE WAS ALSO TRACED TO THE REPORTED ISSUE. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. G3 (DATE RECEIVED BY MANUFACTURER), G4 (PMA / 510(K)#: K141965; K160450), G6 TYPE OR REPORT - FOLLOW UP# 1), H2 (CORRECTION AND ADDITIONAL INFORMATION), H4 (DEVICE MANUFACTURING DATE IS UNKNOWN), H6 ANNEX A (MEDICAL DEVICE PROBLEM CODE), ANNEX B (TYPE OF INVESTIGATION), ANNEX C (INVESTIGATION FINDINGS), ANNEX D (INVESTIGATION CONCLUSIONS), (ANNEX G ¿ COMPONENT CODE). 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 DURING REMOVAL OF THE BANDAGE ON THE PLEURX PLEURAL CATHETER, A HOLE WAS DISCOVERED JUST BEHIND THE VALVE. IT WAS FURTHER REPORTED THAT THE HOLE WAS MADE PROBABLY WITH THE SCISSORS USED TO REMOVE THE BANDAGE. THE ISSUE WAS RESOLVED BY REPLACING WITH A NEW VALVE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING REMOVAL OF THE BANDAGE ON THE PLEURX PLEURAL CATHETER, A HOLE WAS DISCOVERED JUST BEHIND THE VALVE. IT WAS FURTHER REPORTED THAT THE HOLE WAS MADE PROBABLY WITH THE SCISSORS USED TO REMOVE THE BANDAGE. THE ISSUE WAS RESOLVED BY REPLACING WITH A NEW VALVE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551292 PLEURX APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN 10885403075988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown