BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASEPT

    MDR report key: 8095184 · Received November 21, 2018

    Report

    Report Number
    2032582-2018-00006
    Event Type
    Malfunction
    Date Received
    November 21, 2018
    Date of Event
    November 5, 2018
    Report Date
    November 21, 2018
    Manufacturer
    PFM MEDICAL, INC.
    Product Code
    DWM
    UDI-DI
    04046964317514
    PMA / PMN Number
    K093307
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A DHR REVIEW WAS NOT POSSIBLE AS NO LOT INFORMATION WAS PROVIDED. A REVIEW OF ALL NON-CONFORMING PRODUCT WAS CONDUCTED. NO ISSUES WERE FOUND PERTAINING TO REF (B)(4). DURING THE INVESTIGATION OF THE RETURNED SAMPLE, IT WAS FOUND THAT A SMALL SLIT WAS CUT INTO THE TUBING ON THE EXIT SITE OF THE DRAIN LINE. THIS WAS LIKELY CAUSED BY THE USER. IT IS RECOMMENDED THAT WHEN APPLYING SUTURES THE OPERATOR CUTS THE EXCESS SUTURE AWAY FROM THE DRAIN LINE. THIS LIMITS THE CHANCE OF CUTTING INTO THE DRAIN LINE AND CREATING A LEAK. THE ROOT CAUSE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. PFM MEDICAL, INC. WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    CUSTOMER AND PATIENT REPORTED BUBBLES PRESENT IN THE DRAIN LINE THROUGHOUT THE ENTIRE DRAINAGE PROCEDURE. CATHETER WAS PLACED DURING THE WEEK OF (B)(6) 2018. PHYSICIAN NOTICED A SLIT IN THE CATHETER CLOSE TO ENTRY SITE ON (B)(6) 2018. CATHETER WAS REMOVED. ACCOUNT WILL WAIT FOR PATIENT TO HEAL AND POTENTIALLY PLACE ANOTHER CATHETER. CUSTOMER WAS NOT SURE IF THE SLIT WAS CAUSED BY ANYTHING DONE BY THE PHYSICIAN OR STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937562 ASEPT APPARATUS, SUCTION, PATIENT CARE DWM PFM MEDICAL, INC. 622289 UNKNOWN 04046964317514

    Patients

    Seq Age Sex Outcome Treatment
    1 Other