BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLEURX DRAINAGE KIT 1000ML - 50-7510

    MDR report key: 12217637 · Received July 23, 2021

    Report

    Report Number
    9680904-2021-00073
    Event Type
    Malfunction
    Date Received
    July 23, 2021
    Date of Event
    July 7, 2021
    Report Date
    August 16, 2021
    Product Code
    DWM
    UDI-DI
    10885403090707
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PR 3210561 FOLLOW-UP EMDR FOR DEVICE EVALUATION: THREE PHOTOS AND ONE SAMPLE WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, EXCESS MATERIAL IS OBSERVED ON THE SURFACE OF THE ACCESS TIP, VERIFYING THE REPORTED FAILURE. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR REPORTED LOT 0001401637 WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS RELATED TO THIS INCIDENT WERE FOUND, ALL PROCEDURAL AND FUNCTIONAL REQUIREMENTS FOR PRODUCT RELEASE HAVE BEEN MET. GENERAL WEAR ON THE MANUFACTURING EQUIPMENT CAN CONTRIBUTE TO THIS DEFECT. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT MANUFACTURING, ANY PRODUCT IDENTIFIED DURING THESE INSPECTIONS UNDERGOES A PROCESS TO REMOVE THE EXCESS PIECES ON THE ACCESS TIP. IT WAS DETERMINED THIS FAILURE IS DUE TO THE MACHINE AS WELL AS PERSONNEL NOT FOLLOWING PROCEDURE TO PROPERLY REMOVED THE EXCESS PIECES AT THE ACCESS TIP. A CORRECTIVE ACTION PROJECT WAS OPENED TO FURTHER INVESTIGATE AND ADDRESS THIS ISSUE. INCREASED INSPECTIONS WILL BE PERFORMED, AND ADDITIONAL TRAINING WILL BE IMPLEMENTED WITH ALL PERSONNEL. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE MANUFACTURER HERE.

    Description of Event or Problem · 0

    MATERIAL NO: 50-7510 BATCH NO: 0001401637.   IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH TUBE LEAK DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: TUBE LEAK. 15JUL21 - SPOKE TO CUSTOMER - EXPLAINED THAT THEY EXPERIENCED LEAKAGE (DRIPPING) AT THE CONNECTION TO THE CATHETER - THEY LOOKED AT THE ACCESS TIP AND NOTICED THAT IT LOOKED DEFORMED WITH ROUGH/BUMPS NEAR TIP - THEY REPLACED BOTTLE WITH ANOTHER FROM BOX SUCCESSFULLY - THEY TOOK PICTURES AND KEPT BOTTLE - NO PT HARM.

    Additional Manufacturer Narrative · 1

    (B)(4) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    MATERIAL NO: 50-7510, BATCH NO: 0001401637. ¿ IT WAS REPORTED: CUSTOMER RECEIVED KIT WITH TUBE LEAK DEFECTIVE ISSUE; NO PT HARM. EVENT DESCRIPTION STATES: TUBE LEAK. 15JUL21 - SPOKE TO CUSTOMER - EXPLAINED THAT THEY EXPERIENCED LEAKAGE (DRIPPING) AT THE CONNECTION TO THE CATHETER - THEY LOOKED AT THE ACCESS TIP AND NOTICED THAT IT LOOKED DEFORMED WITH ROUGH/BUMPS NEAR TIP - THEY REPLACED BOTTLE WITH ANOTHER FROM BOX SUCCESSFULLY - THEY TOOK PICTURES AND KEPT BOTTLE - NO PT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1115654 PLEURX DRAINAGE KIT 1000ML - 50-7510 APPARATUS, SUCTION, PATIENT CARE DWM 50-7510 0001401637 10885403090707

    Patients

    Seq Age Sex Outcome Treatment
    1 Other