BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MIC-KEY* GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT® CONNECTOR

    MDR report key: 6559514 · Received May 11, 2017

    Report

    Report Number
    9611594-2017-00077
    Event Type
    Injury
    Date Received
    May 11, 2017
    Report Date
    May 17, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    KNT
    UDI-DI
    10680651427486
    PMA / PMN Number
    K043114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 11 MAY 2017 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

    ALL INFORMATION REASONABLY KNOWN AS OF 25 MAY 2017 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 (B)(4).

    Additional Manufacturer Narrative · 1

    THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. NO ROOT CAUSE COULD BE DETERMINED. THE DEVICE HISTORY RECORD FOR AA6060F08 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. ALL INFORMATION REASONABLY KNOWN AS OF 2017-05-05 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). DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    PER ADDITIONAL INFORMATION RECEIVED, THE PATIENT REPORTED TO THE DISTRIBUTOR THAT WHEN THE PRODUCT WAS REPLACED, IT WAS REPLACED WITH EARLIER RECEIVED STOCK THAT SHE STILL HAD ON HAND.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PATIENT THAT THEY RECEIVED A NEW PEG TUBE IN THE BEGINNING OF 2017 THAT THEY HAD NEVER USED BEFORE. AFTER THE PLACEMENT OF THIS PEG, THE PATIENT ALLEGES THAT AN ALLERGIC REACTION BEGAN OUTSIDE OF THE STOMACH, IN THE FORM OF WOUNDS, WHICH THE PATIENT TREATED THEMSELVES. AFTER THAT, THE PATIENT ALLEGES STOMACH FLU LIKE SYMPTOMS AND INCREASING WEAKNESS, WITH DIFFICULTY BREATHING, EVEN ON RESPIRATOR. THE PATIENT WENT TO THE HOSPITAL WHERE THE PATIENT ALLEGES THEY WERE DIAGNOSED WITH SEPSIS AND PNEUMONIA. ON THE ADVICE OF THE HOSPITAL PHYSICIAN, THE PEG TUBE WAS SWITCHED OUT WITH A TYPE THAT THE PATIENT HAD USED BEFORE, UPON WHICH THE PATIENT ALLEGES THAT ALL SYMPTOMS RESOLVED. THE PATIENT REPORTED THAT THEY HAVE COMPLETELY RECUPERATED. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341670 MIC-KEY* GASTROSTOMY FEEDING TUBE EXTENSION SETS WITH ENFIT® CONNECTOR DH EF BALLOON TUBES PRODUCTS KNT HALYARD HEALTH 8140-16-2.5 AA6060F08 10680651427486

    Patients

    Seq Age Sex Outcome Treatment
    1 24 YR