BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 3.0 CM, 45 CM

    MDR report key: 7964623 · Received October 15, 2018

    Report

    Report Number
    9611594-2018-00160
    Event Type
    Malfunction
    Date Received
    October 15, 2018
    Date of Event
    September 14, 2018
    Report Date
    October 10, 2018
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651956672
    PMA / PMN Number
    K926581
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AVANOS MEDICAL RECEIVED ONE USED MICKEY TJ SAMPLE, ONE BOLUS EXTENSION SET, ONE WHITE STEP CONNECTOR, ONE UNIDENTIFIED WIRE TIED TO THE DISTAL END OF THE MICKEY TJ. THE MICKEY TJ SAMPLE EXHIBITED BROWN DISCOLORATION. THE OUTER SURFACE OF THE TUBING HAD BROWN, BUMPY CLUSTERS ADHERED TO THE SILICONE. THE TUBING WAS SEVERED APPROXIMATELY 4 CM BELOW THE BALLOON DISTAL COLLAR. THE JEJUNAL PORT HOUSING WAS DETACHED FROM THE MOLDED HEAD. THE DETACHED FEED PORT WAS NOT RETURNED. THE SUBJECT SAMPLE PROVIDED WAS EVALUATED AND CONFIRMED A TUBE SEVERED APPROXIMATELY 4 CM BELOW THE BALLOON DISTAL COLLAR. HOWEVER, THERE WERE NO FOUND ACTIVITIES OR TOOLS THAT COULD CAUSE THIS TYPE OF FLAW IN THE TUBE COMPONENT. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF 22-OCT-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 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.

    Description of Event or Problem · 0

    USER FACILITY REPORT (B)(4) WAS RECEIVED ON 16-OCT-2018 FROM THE FDA. NO NEW INFORMATION RECEIVED.

    Additional Manufacturer Narrative · 1

    ACTUAL COMPLAINT PRODUCT IS REPORTED TO BE AVAILABLE BUT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE REPORTED LOT NUMBER, AA7275N32, WAS REVIEWED AND DOCUMENTED THAT THE LOT WAS MANUFACTURED ACCORDING TO THE APPROVED MANUFACTURING PROCEDURES, SPECIFICATIONS, AND THEN RELEASED BY QUALITY ASSURANCE. ALL INFORMATION REASONABLY KNOWN AS OF 03-OCT-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 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S GJ TUBE BROKE INSIDE OF HIM. THE PATIENT WAS SCHEDULED FOR A 3-MONTH ROUTINE TUBE CHANGE. THE GROUP HOME NOTED NO ISSUES WITH THE TUBE. WHEN A WIRE WAS PUT IN AND NO RESISTANCE WAS FELT, IT WAS AT THAT TIME WHEN THEY WERE USING FLUOROSCOPY THAT IT WAS DISCOVERED THE J-TUBE DETACHED FROM THE G-TUBE. THEY WERE ABLE TO LOCATE THE DETACHED PORTION AND REMOVED IT. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2018 STATED THAT THE PATIENT WAS AN OUTPATIENT FROM A GROUP HOME WITH CEREBRAL PALSY. IT WAS NOTED THAT THE PATIENT LEFT IN THE SAME CONDITION THAT HE CAME TO THEM IN, AND EXPERIENCED NO INJURY FROM THE TUBE. ON (B)(6) 2018, THE CUSTOMER FORWARDED AVANOS MEDICAL A COPY OF THE MEDWATCH USER FACILITY REPORT THEY FILED REFERENCE (B)(4): "ON (B)(6) 2018, THE PATIENT HAD A SCHEDULED GASTROJEJUNOSTOMY TUBE PLACEMENT. THE EXCHANGE OF THE 18 FRENCH GASTROJEJUNOSTOMY TUBE WENT AS PLANNED. APPROPRIATE POSITION WAS CONFIRMED WITH CONTRAST INJECTION. RETENTION BALLOON WAS THEN INFLATED. NO COMPLICATIONS WERE NOTED. PATIENT SENT BACK TO GROUP HOME RESIDENCE. THE PATIENT WAS SCHEDULED FOR (B)(6), FOR THE NEXT ROUTINE GASTROJEJUNOSTOMY TUBE REPLACEMENT. THE GROUP HOME HAD REPORTED NO ISSUES WITH THE TUBE. ON (B)(6), DURING THE PROCEDURE, THE WIRE WAS PLACED IN A RESISTANCE NOTED) AND DISCOVERED WHEN STEPPED ON FLUORO THAT THE J-TUBE PORTION HAD DETACHED FROM THE G-TUBE PORTION. THE INTERVENTIONAL RADIOLOGY TEAM WAS ABLE SNARE THE BROKEN EXISTING J LIMB AND REMOVE IT. THE NEW 18 FRENCH GASTROJEJUNOSTOMY TUBE WAS INSERTED THROUGH THE EXISTING TRACT INTO THE JEJUNUM. THIS WAS A SUCCESSFUL REPLACEMENT OF A BROKEN GASTROJEJUNOSTOMY TUBE WITH NO COMPROMISE TO OUR PATIENT. HALYARD HEALTH WAS NOTIFIED OF THE EVENT." ON (B)(6) 2018, AVANOS MEDICAL RECEIVED USER FACILITY REPORT WITH REFERENCE (B)(4). NO NEW INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807153 MIC-KEY LOW-PROFILE TRANSGASTRIC-JEJUNAL FEEDING TUBE, 18 FR, 3.0 CM, 45 CM DH EF BALLOON TUBES PRODUCTS KNT AVANOS MEDICAL INC. 0270-18-3.0-45 AA7275N32 10680651956672

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR