BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX PLEURAL CATHETER MINI KIT

    MDR report key: 21981324 · Received May 7, 2025

    Report

    Report Number
    1625685-2025-00038
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 15, 2025
    Report Date
    May 29, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403075988
    PMA / PMN Number
    K160450
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: THE LOT NUMBER FOR THE DEVICE WAS PROVIDED. THE DEVICE HISTORY RECORDS ARE CURRENTLY UNDER REVIEW. PHOTOS WERE PROVIDED AND REVIEW IS CURRENTLY UNDERWAY. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION THE INVESTIGATION IS CURRENTLY UNDERWAY. H10 : D4 (EXPIRATION DATE: 03/2027). 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

    H10: MANUFACTURING REVIEW: A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER 0001563332 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND. PRODUCT UNDERGOES INSPECTIONS DURING MANUFACTURING, NO ISSUES RELATED TO THE REPORTED INCIDENT WERE IDENTIFIED, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. H10: INVESTIGATION SUMMARY: ONE PHOTO SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE PHOTO, WE ARE UNABLE TO CONFIRM THE REPORTED FAILURE. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H10: B5 (DESCRIBE EVENT OR PROBLEM), G4 (DATE RECEIVED BY MANUFACTURER), G7 (TYPE OF REPORT; FOLLOW-UP # 1). H11: B1 (ADVERSE TYPE), B2 (EVENT ATTRIBUTED TO), H1 (TYPE OF REPORTABLE EVENT), H2 (CORRECTION, ADDITIONAL INFORMATION). H11: H6 (ANNEX F CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS). 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.

    Description of Event or Problem · 0

    THE PATIENT WAS CARED FOR IN (B)(6). HE HAS A PLEURX DRAIN WITH A CRACK IN THE SCREW OUTLET. THERE IS A RISK THAT THIS MAY BREAK IN THE NEAR FUTURE, WHICH WOULD COMPROMISE THE DRAINAGE CURRENTLY PERFORMED EVERY 36 HOURS. DECISION TO CHANGE THE DRAIN. FOR THE MOMENT, THE DRAIN HAS NOT YET BEEN REPLACED (AND MAY NOT BE, AS YOUR SALES REPRESENTATIVE HAS COME UP WITH A SOLUTION TO REPLACE THE VALVE). AS PER FOLLOW-UP: THE CONSEQUENCES ARE: DRAINAGE DIFFICULTIES WITH A DAMAGED VALVE. THE PATIENT HAS TO RETURN TO THE CENTER TO HAVE EITHER THE VALVE REPLACED OR THE ENTIRE DRAIN REPLACED IF THIS IS NOT POSSIBLE (INCLUDING HOSPITALIZATION). FOLLOW-UP INFORMATION RECEIVED ON 04-25-2025: 1. WAS THE VALVE CRACKED OR BROKEN? IT WAS INITIALLY CRACKED THEN EVENTUALLY BROKE, THE TUBING WAS CLAMPED BECAUSE OF THE RISK OF INFECTION+++. 2. WHERE IS THE CATHETER LOCATED? IN THE ABDOMEN OR IN THE CHEST? SEE PHOTO. 3. HOW LONG HAS THE CATHETER BEEN IN PLACE? INSERTED IN (B)(6) 2024. 4. HOW WAS THE PROBLEM SOLVED? OUR RADIOLOGIST CHANGED THE VALVE. 5. PLEASE CONFIRM IF THE VALVE HAS BEEN REPLACED OR IF THE PLEURX CATHETER HAS BEEN REPLACED? VALVE REPLACEMENT. 6. WERE THEY ABLE TO DRAIN SUCCESSFULLY? NO. 7. IS THERE A PHOTO OR SAMPLE SHOWING THE PROBLEM REPORTED? NO. 8. WAS MEDICAL INTERVENTION REQUIRED, INCLUDING DIAGNOSIS, PROCEDURES AND TREATMENT TIMES? YES.

    Description of Event or Problem · 0

    HE HAS A PLEURX DRAIN WITH A CRACK IN THE SCREW OUTLET. THERE IS A RISK THAT THIS MAY BREAK IN THE NEAR FUTURE, WHICH WOULD COMPROMISE THE DRAINAGE CURRENTLY PERFORMED EVERY 36 HOURS. DECISION TO CHANGE THE DRAIN. FOR THE MOMENT, THE DRAIN HAS NOT YET BEEN REPLACED (AND MAY NOT BE, AS YOUR SALES REPRESENTATIVE HAS COME UP WITH A SOLUTION TO REPLACE THE VALVE). AS PER FOLLOW-UP: THE CONSEQUENCES ARE: DRAINAGE DIFFICULTIES WITH A DAMAGED VALVE. THE PATIENT HAS TO RETURN TO THE CENTER TO HAVE EITHER THE VALVE REPLACED OR THE ENTIRE DRAIN REPLACED IF THIS IS NOT POSSIBLE (INCLUDING HOSPITALIZATION). VALVE WAS INITIALLY CRACKED THEN EVENTUALLY BROKE, THE TUBING WAS CLAMPED BECAUSE OF THE RISK OF INFECTION. THE CATHETER HAD BEEN INSERTED IN NOVEMBER 2024. THE VALVE WAS SUBSEQUENTLY REPLACED, BUT THE ISSUE RESULTED IN A DELAY IN TREATMENT. HOSPITALIZATION HAS OCCURRED FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035675 PLEURX PLEURAL CATHETER MINI KIT APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC 0001563332 10885403075988

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| O