BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IPC

    MDR report key: 25032005 · Received April 29, 2026

    Report

    Report Number
    3002808026-2026-00005
    Event Type
    Malfunction
    Date Received
    April 29, 2026
    Date of Event
    March 24, 2026
    Report Date
    April 17, 2026
    Manufacturer
    ROCKET MEDICAL PLC
    Product Code
    DWM
    PMA / PMN Number
    K123033
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN ASSISTANT
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE STILL IMPLANTED IN PATIENT AND UNABLE TO BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    EXACT WORDING OF COMPLAINT RECEIVED FROM CUSTOMER: 'INDWELLING PLEURAL CATHETER INSERTED (B)(6) 2025 FOR MALIGNANT LEFT PLEURAL EFFUSION. INDEPENDENT DRAINAGE IN THE COMMUNITY WITHOUT SIGNIFICANT ISSUES THUS FAR. DRAINAGE TECHNIQUE OBSERVED BY RESPIRATORY TEAM AT TIME OF INSERTION AND RECENTLY, WITH NO ISSUES IDENTIFIED. SMALL PARTIAL-THICKNESS LACERATION TO EXTERNAL IPC LINE CAUSING A SMALL HOLE WITH PLEURAL FLUID LEAKAGE. FIRST IDENTIFIED (B)(6) 2026 (A&E - RESPIRATORY TEAM NOT MADE AWARE UNTIL (B)(6) 2026 AFTER PATIENT CONTACTED FOR ADVICE). PATIENT REVIEWED IN PLEURAL CLINIC (B)(6) 2026- SMALL IRREGULAR LACERATION CONFIRMED WITH A ~1 MM HOLE VISIBLE HALFWAY ALONG THE EXTERNAL PORTION OF THE IPC. THOROUGH HISTORY TAKEN: PATIENT AND NEXT-OF-KIN ARE CERTAIN THERE HAS BEEN NO SHARP OBJECTS NEAR THE IPC AT ANY TIME. UNABLE TO IDENTIFY ANY CAUSE; MECHANICAL OR OTHERWISE. IPC LAST DRAINED AT HOME BY PATIENT (B)(6) 2026 - NO VISIBLE DAMAGE REPORTED BY PATIENT AT THIS TIME. LEAK IDENTIFIED ON REMOVAL OF A WET DRESSING IN A&E (B)(6) 2026. IPC NOT INTERACTED WITH BETWEEN THESE TWO DATES. STANDARD IPC DRESSING INCLUDED WITH KIT USED. NO HARM TO PATIENT AT TIME OF CLINIC REVIEW (B)(6) 2026. RISK OF HARM VIA LOSS OF STERILITY & PROGRESSION TO EMPYEMA. RISK OF HARM VIA AIR ENTRAINMENT RESULTING IN OPEN PNEUMOTHORAX. VALVE REPLACEMENT KIT USED REDUCE LINE LENGTH AND REPLACE VALVE (R54410-00-VV). THE PATIENT HAS PROVIDED VERBAL CONSENT TO BE CONTACTED BY ROCKET MEDICAL FOR FURTHER INFORMATION, IF REQUIRED - DOCUMENTED IN PATIENT NOTES. INFORMATION AVAILABLE ON REQUEST VIA EMAIL TO SECURE EMAIL ADDRESS.' ROCKET MEDICAL EXPLANATION: WE ARE UNABLE TO OBTAIN THE DEVICE BACK AND NO FURTHER INVESTIGATION COULD BE DONE. IMAGES WERE PROVIDED AND CONFIRMS THE DAMAGE REPORTED HOWEVER WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36818 IPC IPC INSERTION SET WITH METAL TUNNELER DWM ROCKET MEDICAL PLC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R