BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORFLO* NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR

    MDR report key: 7233695 · Received February 1, 2018

    Report

    Report Number
    3009124963-2018-00006
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    December 29, 2017
    Report Date
    March 16, 2018
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10815149020591
    PMA / PMN Number
    K821906
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS REPORTED TO BE AVAILABLE BUT NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ALL INFORMATION REASONABLY KNOWN AS OF 31-JAN-2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: SAMPLE DEVICE RETURNED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RECEIVED. NO PRODUCT PACKAGING WAS RECEIVED. THE PRODUCT DID NOT CONTAIN A LOT NUMBER IDENTIFICATION. THE TUBING EXHIBITED DISCOLORATION FROM THE POINT OF SEPARATION TO APPROXIMATELY THE 75 CM MARKING. AT THE 54 CM MARK, THE TUBING EXHIBITED STRETCHING OR "BALLOONING" AND HAD RUPTURED AND SEPARATED. THE DETACHED DISTAL PORTION OF THE TUBE WAS NOT RETURNED FOR EVALUATION. WATER WAS FLUSHED THROUGH THE FEEDING ADAPTER ON THE PROXIMAL END OF THE TUBE. NO OCCLUSION OR RESTRICTION OF FLOW WAS OBSERVED. NO OTHER DAMAGE WAS OBSERVED ON THE SAMPLE. THE ROOT CAUSE WAS INAPPROPRIATE USE. THIS ISSUE WAS CAUSED BY EXCESSIVE PRESSURE CAUSED BY TRYING TO UNCLOG THE TUBE BY FLUSHING. ALL INFORMATION REASONABLY KNOWN AS OF 10-APR-2018 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 HALYARD HEALTH 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 HALYARD HEALTH. HALYARD HEALTH 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 HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2017 THE PATIENT WAS SCHEDULED TO HAVE THE EXISTING CORFLO RADIOLOGICALLY PLACED NASOJEJUNAL TUBE (NJT) ADVANCED. THE TIP OF THE EXISTING TUBE, WHICH WAS PLACED (B)(6) 2017, HAD RETRACTED INTO THE DUODENUM. THE MAIN BODY OF THE TUBE HAD COILED INTO THE PATIENT'S STOMACH AFTER THE PATIENT HAD VOMITED. AN INITIAL X-RAY NOTED THE NJT TO BE COILED IN THE STOMACH, SO A 260 CM STIFF TERUMO GUIDE WIRE WAS INSERTED DOWN THE TUBE. WHEN THE WIRE WAS PARTIALLY INSERTED THE HEALTHCARE PRACTIONER PROCEEDED TO WITHDRAW THE NJT UNDER FLUOROSCOPIC GUIDANCE IN ORDER TO UNCOIL THE LOOP IN THE STOMACH IN AN EFFORT TO AID IN ADVANCEMENT. INITIALLY THE LOOPED TUBE WAS SEEN TO MOVE AS THE HEALTHCARE PRACTIONER WITHDREW THE TUBE. THE HEALTHCARE PRACTIONER CONTINUED TO WITHDRAW THE TUBE. IT BECAME APPARENT THAT THE TUBE HAD FRACTURED INTO TWO PIECES AND THE PROXIMAL PORTION WAS REMOVED VIA THE NOSE. CONFIRMATION VIA X-RAY NOTED THE DISTAL 55 CM OF THE NJT TO BE IN THE PATIENT¿S STOMACH. ADDITIONAL INFORMATION RECEIVED 11-JAN-2018 STATED THE HEALTHCARE PRACTIONER RECOVERED ALL PARTS OF THE TUBE. THE PATIENT REQUIRED AN ENDOSCOPY PROCEDURE FOR REMOVAL OF THE RETAINED DEVICE COMPONENT. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77994 CORFLO* NASOGASTRIC/NASOINTESTINAL FEEDING TUBE WITH STYLET WITH ENFIT CONNECTOR DH CPK NG TUBES KNT HALYARD HEALTH 42-7558 UNKNOWN 10815149020591

    Patients

    Seq Age Sex Outcome Treatment
    1