BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOCKABLE DRAINAGE LINE

    MDR report key: 17984855 · Received October 23, 2023

    Report

    Report Number
    9680904-2023-00038
    Event Type
    Malfunction
    Date Received
    October 23, 2023
    Date of Event
    October 4, 2023
    Report Date
    December 1, 2023
    Manufacturer
    CAREFUSION, INC
    Product Code
    DWM
    UDI-DI
    10885403502385
    PMA / PMN Number
    K160450
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW-UP EMDR FOR DEVICE EVALUATION: FOUR PHOTOS SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. UPON VISUAL INSPECTION, IT WAS OBSERVED THAT THERE IS A YELLOW SUBSTANCE IN THE SURFACE OF THE LOCKING ACCESS DILATOR COMPONENT. BASED ON THE VISUAL INSPECTION PERFORMED, THE FAILURE MODE COULD BE CONFIRMED. A DEVICE HISTORY RECORD COULD NOT BE EVALUATED AS THE LOT NUMBER IS UNKNOWN. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND DEFECT WILL CONTINUE TO BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PR 9024666 INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE PROBLEM CODE: A1801. PATIENT PROBLEM CODE: F24 H3 OTHER TEXT : SEE MANUFACTURE NARRATION.

    Description of Event or Problem · 0

    MAT# 50-7245A LOT# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THREE OF THESE WERE CONTAMINATED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED REGARDING ORDER CONFIRMATION (B)(4), PO 12723762, ITEM 50-7245A, DRN LN LK PLEURX PERITX THREE OF THESE WERE CONTAMINATED.

    Description of Event or Problem · 0

    MAT# 50-7245A LOT# UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THREE OF THESE WERE CONTAMINATED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. REGARDING ORDER CONFIRMATION 5008899844, PO 12723762, ITEM 50-7245A, DRN LN LK PLEURX PERITX THREE OF THESE WERE CONTAMINATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125252 LOCKABLE DRAINAGE LINE APPARATUS, SUCTION, PATIENT CARE DWM CAREFUSION, INC UNKNOWN 10885403502385

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown