BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLEURX DRAINAGE KIT 1000ML

    MDR report key: 21405734 · Received February 18, 2025

    Report

    Report Number
    9680904-2025-00002
    Event Type
    Injury
    Date Received
    February 18, 2025
    Date of Event
    January 28, 2025
    Report Date
    March 20, 2025
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    PMA / PMN Number
    K160450
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. H10: INVESTIGATION SUMMARY: NO PHOTOS OR SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION THEREFORE THE FAILURE MODE COULD NOT BE VERIFIED. THEREFORE, THE INVESTIGATION RESULT IS INCONCLUSIVE FOR THE REPORTED INCIDENT. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. H10: B3: DATE OF EVENT WAS NOT PROVIDED. THEREFORE, DATE OF AWARENESS, 01/28/2025 WAS ENTERED INSTEAD IN THE DATE OF EVENT FIELD. B5 (DESCRIBE EVENT OR PROBLEM), D2 (PROCODE: DWM, PNG), G4 (DATE RECEIVED BY MANUFACTURER), G5 (PMA/510(K): K160437, K160450, K201155), G7 (FOLLOW UP # - 1), H2 (CORRECTION, ADDITIONAL INFORMATION), H6 (COMPONENT CODE). H11: E4 (FDA NOTIFIED?), H6 (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.

    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 WAS NOT RETURNED. THE INVESTIGATION IS CURRENTLY UNDERWAY. H10: DATE OF EVENT WAS NOT PROVIDED. THEREFORE, DATE OF AWARENESS, 01/28/2025 WAS ENTERED INSTEAD IN THE DATE OF EVENT FIELD. 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

    IT WAS REPORTED THAT THE PATIENT HAD AN ALLERGIC REACTION TO THE PLEURX DRAINAGE ADHESIVE IN THE KIT. PATIENT STATUS WAS NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THE PATIENT IS HAVING AN ALLERGIC REACTION TO ADHESIVE IN THE KIT. PATIENT STATUS WAS NOT PROVIDED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. AUTH SAID THE PATIENT IS HAVING A ALLERGIC REACTION TO ADHESIVE IN THE KIT. IT IS UNCLEAR IF THE LOT NUMBER WAS REQUESTED. NO ADDITIONAL INFORMATION PROVIDED. PRODUCT NUMBER: 507510.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60210 PLEURX DRAINAGE KIT 1000ML APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention