BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PATIENT TUBING FOR USE WITH DRYDOC VACUUM STATION

    MDR report key: 9833027 · Received March 14, 2020

    Report

    Report Number
    1018233-2020-01834
    Event Type
    Injury
    Date Received
    March 14, 2020
    Report Date
    April 21, 2020
    Manufacturer
    ADAPTEC MEDICAL DEVICES LLC 3014271001
    Product Code
    NZU
    UDI-DI
    00801741151811
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS INCONCLUSIVE AS NO SAMPLE WAS RETURNED FOR EVALUATION. A POTENTIAL ROOT CAUSE COULD BE DUE TO ¿INADEQUATE MATERIAL SELECTION - MATERIALS OF CONSTRUCTION ARE NOT BIOCOMPATIBLE¿. THE LOT NUMBER IS UNKNOWN; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. THE INSTRUCTIONS FOR USE WERE FOUND ADEQUATE AND STATE THE FOLLOWING: "PERFORM PERINEAL CARE AND ASSESS SKIN INTEGRITY" AND "REPLACE THE PUREWICKTM FEMALE EXTERNAL CATHETER AT LEAST EVERY 8-12 HOURS OR IF SOILED WITH FECES OR BLOOD". H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF 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. H3 OTHER TEXT : THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL GROWTH INSIDE OF THE PATIENT TUBING THAT HAS MADE THE PATIENT SICK. THE PATIENT'S DOCTOR ALLEGED THAT THE BACTERIAL GROWTH CAUSED A BACTERIA INFECTION. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE INFECTION.

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE A SUPPLEMENTAL REPORT WILL BE FILED. THE DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BACTERIAL GROWTH INSIDE OF THE PATIENT TUBING THAT HAS MADE THE PATIENT SICK. THE PATIENT'S DOCTOR ALLEGED THAT THE BACTERIAL GROWTH CAUSED A BACTERIA INFECTION. IT IS UNKNOWN WHAT MEDICAL INTERVENTIONS WERE GIVEN FOR THE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296274 PATIENT TUBING FOR USE WITH DRYDOC VACUUM STATION PATIENT TUBING NZU ADAPTEC MEDICAL DEVICES LLC 3014271001 UNK 00801741151811

    Patients

    Seq Age Sex Outcome Treatment
    1 Other