BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIGESTHEALTH ENTERAL FEED DEVICE TUBE KITS

    MDR report key: 5658607 · Received May 16, 2016

    Report

    Report Number
    9611594-2016-00087
    Event Type
    Malfunction
    Date Received
    May 16, 2016
    Date of Event
    March 21, 2018
    Report Date
    April 28, 2016
    Manufacturer
    HALYARD HEALTH
    Product Code
    KCG
    PMA / PMN Number
    PUNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UDI # UNKNOWN. (B)(4). THE ACTUAL COMPLAINT PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD IS NOT POSSIBLE AS A LOT NUMBER WAS NOT PROVIDED AND A ROOT CAUSE CANNOT BE DETERMINED. 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). DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ALL INFORMATION REASONABLY KNOWN AS OF 28MAR2018 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. 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

    A MEDWATCH REPORT WAS RECEIVED ON 18-APR-2016, AND FDA REPORT NUMBER (B)(4) WAS IDENTIFIED. THE REPORT STATES, A PATIENT WAS HAVING A GASTROSTOMY FEEDING TUBE PLACEMENT UNDER MODERATE CONSCIOUS SEDATION. A GASTROSTOMY FEEDING TUBE WAS PLACED IN THE LUMEN OF THE STOMACH, GUIDED BY US AND FLUORO. THE PATIENT RETURNED APPROXIMATELY NINE MONTHS LATER WITH ACUTE ABDOMINAL PAIN; THE IMAGING SHOWED A FOREIGN OBJECT NEAR THE STOMACH ALONG WITH FREE AIR. A DIAGNOSTIC LAPAROSCOPY WAS PERFORMED TO REMOVE THE OBJECT, WHICH APPEARS TO BE AN INTERNAL PORTION OF THE DILATOR USED DURING THE GASTROSTOMY TUBE PLACEMENT. THE PATIENT UNDERWENT AN UNEVENTFUL POST-OP COURSE WITH THE RETURN OF NORMAL BOWEL AND BLADDER FUNCTION. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313502 DIGESTHEALTH ENTERAL FEED DEVICE TUBE KITS DIGESTHEALTH ENTERAL FEED DEVICE TUBE KITS KCG HALYARD HEALTH UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other