BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN CORPAK NASOGATRIC TUBE

    MDR report key: 17740178 · Received September 13, 2023

    Report

    Report Number
    9611594-2023-00130
    Event Type
    Malfunction
    Date Received
    September 13, 2023
    Date of Event
    July 14, 2023
    Report Date
    September 13, 2023
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    FPD
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE IS REPORTED TO BE AVAILABLE BUT HAS NOT BEEN RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2023 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AVANOS MEDICAL, INC. 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 AVANOS MEDICAL, INC. AVANOS MEDICAL, INC. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AVANOS MEDICAL, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AVANOS MEDICAL, INC. PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE "REQUIRED REMOVAL DUE TO OCCLUSION. BRIDLE WAS UNCLAMPED, TUBING WAS EASILY REMOVED WITHOUT RESISTANCE. TUBING RETAINED WAS NOTABLY SHORTER IN LENGTH. UPON CLOSER OBSERVATION, TUBING TIP APPEARED RUPTURED/SEVERED. [PATIENT] WITHOUT COMPLAINTS. [PHYSICIAN] WAS NOTIFIED. [A KIDNEY, URETER, AND BLADDER X-RAY] KUB PERFORMED SHOWING RETAINED TUBING REMNANT." THE RETAINED TUBING WAS REMOVED. THE CLINICIAN NOTES THE PATIENTS' HISTORY IS UNKNOWN AT VISIT (SEVERAL TUBE PLACEMENTS AND REPEATED TUBE CLOGGING) UNABLE TO DISCERN WHICH METHODS DISCUSSED WITH PT AND WIFE HAD BEEN USED WITH THIS TUBE PRIOR TO BEDSIDE VISIT ON (B)(6) 2023. THE PATIENT'S FAMILY MEMBER WAS GIVEN A 6ML SYRINGE FOR DECLOGS BY THE PROVIDER, ALONG WITH 30ML SYRINGE. THE PATIENT'S FAMILY MEMBER HAD USED THE STYLET, AND PER CHART REVIEW VIOKASE HAD BEEN ORDERED. THE DEVICE WAS PLACED (B)(6) 2023 AND THE PATIENT WAS DISCHARGED (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77831 UNKNOWN CORPAK NASOGATRIC TUBE DH CPK NG TUBES FPD AVANOS MEDICAL INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male VIOKASE