BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL

    MDR report key: 9927118 · Received April 5, 2020

    Report

    Report Number
    3006646024-2020-00007
    Event Type
    Malfunction
    Date Received
    April 5, 2020
    Date of Event
    January 31, 2020
    Report Date
    April 5, 2020
    Manufacturer
    AVANOS MEDICAL INC.
    Product Code
    KNT
    UDI-DI
    00350770409795
    PMA / PMN Number
    K924065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS NO LOT NUMBER WAS PROVIDED. ROOT CAUSE COULD NOT BE DETERMINED. ALL INFORMATION REASONABLY KNOWN AS OF (B)(6) 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 HALYARD HEALTH REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. 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). MW 5093201.

    Description of Event or Problem · 1

    AVANOS MEDICAL, INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT EVENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 3006646024-2020-00008 FOR THE SECOND EVENT. REFER TO 3006646024-2020-00009 FOR THE THIRD EVENT. IT WAS REPORTED VIA FDA MEDWATCH / FDA USER FACILITY REPORT # MW 5093201 RECEIVED ON (B)(6)2020, AND THE FOLLOWING INFORMATION WAS PROVIDED: HALYARD G TUBE WHICH WAS ALMOST 2 YRS OLD AND WAS SUPPOSED TO BE REMOVABLE BY EXTERNAL TRACTION, BROKE UPON REMOVAL ATTEMPT, LEAVING THE INTERNAL BUMPER INSIDE THE STOMACH. URGENT EGO WAS REQUIRED TO REMOVE THE INTERNAL BUMPER FROM THE STOMACH. BUMPER WAS FELT TO TOO LARGE TO BE ALLOWED TO PASS SPONTANEOUSLY SIGNIFICANT CONCERN FOR SMALL BOWEL OBSTRUCTION REQUIRING LAPAROTOMY. IF BUMPER PASSED BEYOND STOMACH DUE TO PERISTALSIS THEREFORE WAS SIGNIFICANT URGENCY FOR ENDOSCOPY. EGD REVEALED SEPARATED INTERNAL BUMPER IN STOMACH SEE ABOVE. UNFORTUNATELY, THIS IS THE MOST DRAMATIC INCIDENT RELATED TOG TUBE AT MY FACILITY. BUT I HAVE SEEN SEVERAL G TUBES OF THIS BRAND RECENTLY THAT WERE DEGRADED WAY BEYOND WHAT THEIR CALENDAR AGE WOULD INDICATE. I HAVE PRE-EMPTIVELY PERFORMED ENDOSCOPY TO REMOVE THEM INSTEAD OF GOING THROUGH WHAT I WENT THROUGH WITH THE PT DESCRIBED ABOVE. I FEEL PTS ARE HAVING TO UNDERGO UNNECESSARY ENDOSCOPIC PROCEDURES. THE MEDIAN AGE OF THESE PREMATURELY DEGRADED G TUBES IS AROUND 4 MONTHS. I AM AWARE OF MFR RECS STATING THAT TUBES MORE THAN FEW MONTHS OLD MAY EXHIBIT THIS PHENOMENON; HOWEVER, I HAVE BEEN WORKING WITH G TUBES FOR ALMOST 20 YRS AND HAVE NOT SEE THIS LEVEL OF DEGRADATION. MATERIALS ISSUES FDA SAFETY REPORT ID# (B)(4). THE TUBE IN QUESTION WAS 360 DAYS OLD. ADDITIONAL INFORMATION RECEIVED 12-MAR-2020 STATED: THERE WERE AT LEAST 2 INSTANCES WHERE A BUMPER SEPARATED FROM THE TUBE. NEITHER PATIENT HAD AN UNUSUAL BODY HABITS IN THE SENSE THAT I DID NOT EXPECT THE ISSUE WAS RELATED TO ABDOMINAL OBESITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389969 MIC SAFETY PERCUTANEOUS ENDOSCOPIC GASTROSTOMY PEG KIT - 20 FR - PULL DH EF PEG INITIAL PLACEMENT PRODUCTS KNT AVANOS MEDICAL INC. 7180-20 UNKNOWN 00350770409795

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR