BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORGRIP NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM

    MDR report key: 8807649 · Received July 19, 2019

    Report

    Report Number
    3011270181-2019-00028
    Event Type
    Malfunction
    Date Received
    July 19, 2019
    Date of Event
    May 25, 2019
    Report Date
    May 3, 2021
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    10680651469059
    PMA / PMN Number
    K162110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD(DHR) AND PROCESS/SYSTEM EVALUATION WERE CONDUCTED USING CORPAK'S DHR FOR THE REPORTED LOT NUMBER IN THIS COMPLAINT, 79122. THE PROCESS/SYSTEM EVALUATION CONCLUDED THE ROOT CAUSE OF THIS INCIDENT WAS INAPPROPRIATE USE. THE INSTRUCTIONS FOR USE (IFU) CLEARLY INDICATES IN THE "SECURING THE CORGRIP* TO THE NG/NI TUBE WITH THE SSL* (SLOT-SLIDE-LOCK) CLAMP" SECTION UNDER STEP 5. "TRIM THE EXCESS UMBILICAL TAPE ABOUT 1 CM BELOW THE KNOT AND DISCARD MAGNET.". ALL INFORMATION REASONABLY KNOWN AS OF 24-JAN-2020 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.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 30-APR-2021 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.

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 18-JUL-2019 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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

    AN MEDWATCH / FDA USER FACILITY REPORT # MW 2200710000-2019-8031 WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: DESCRIBE EVENT: "THE PATIENT WAS BROUGHT TO MRI SCANNER IN THE RADIOLOGY/IMAGING DEPARTMENT TO HAVE A BRAIN SCAN. THE TECHNOLOGIST REPORTED THAT THE MAGNETIC WAND DID NOT INDICATE MAGNETISM NOTED NEAR THE PATIENT'S HEAD. THERE WERE ALSO NO VISIBLE SIGNS OF METAL DETECTED ON THE INSPECTION. IN THE MRI, THE STRING WITH THE MAGNET ATTACHED ON THE END PULLED SUGGESTING METAL PRESENT. UPON CLOSER INSPECTION OF THE CLOTH TAPE OF BRIDLE (NASOGASTRIC TUBE RETENTION SYSTEM), IT REVEALED THAT THE MAGNET TIP WAS STILL ON THE TAPE IMBEDDED IN CLOTH. THE SMALL MAGNET WAS REMOVED AND THE MRI WENT FORTH. ORIGINAL INTENDED PROCEDURE: THE SUGGESTION IS TO CUT OFF END TIP MAGNETS FROM ALL BRIDLES AFTER PLACEMENT PRIOR TO TAKING THE PATIENT TO MRI - TRAINING BEING OFFERED TO THE PROVIDER AND CLINICAL STAFF IN THE ICU BY THE CORGRIP REPRESENTATIVES DURING THE WEEK OF JUNE 16TH. ALSO, SECURE THE FEEDING TUBE A BRIDLE (NGT RETENTION SYSTEM) THAT MATCHES THE CORRECT SIZE OF THE FEEDING TUBE (EX FEEDING TUBE # 12, MATCHING BRIDLE = # 12 BRIDLE FOR SECURE ATTACHMENT). RESOURCE NURSE AND CLINICAL NURSE SPECIALIST OF ICU WERE NOTIFIED OF THE EVENT (BOTH THE MAGNET AND IMPROPER SIZED BRIDLE WERE SAVED FOR THE RESOURCE NURSE AND CNS SCRUTINY). MRI TEAM TAKING PICTURES OF IMBEDDED MAGNET AND MRI SUPERVISOR INFORMED - MRI LEADERS WILL TEST THE MAGNET AGAINST ALL OF THE METAL DETECTING WANS THAT THEY USE FOR PRE-EVALUATION FOR METAL ITEMS (STAFF SURPRISED THAT THIS WAS MISSED BY THE WAND). ADDITIONAL INFORMATION FOR PATIENT #1: OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT. THE PATIENT WAS ORALLY INTUBATED AND VENTILATED AT THE TIME OF THE EVENT. SHE WAS TRANSFERRED FROM THE ICU TO THE MRI SCANNER FOR AN IMAGING STUDY WHEN THIS EVENT OCCURRED. THERE WAS NO HARM TO THE PATIENT (KNOWN) - NEEDED TO HAVE HER FEEDING TUBE REPLACED AFTER THE EVENT. EVENT DATE: (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601349 CORGRIP NASOGASTRIC/NASOINTESTINAL FEEDING TUBE RETENTION SYSTEM DH CPK CORGRIP TUBE RETENTION KNT AVANOS MEDICAL INC. 25-018 79122 10680651469059

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR