BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIDE LOADING CLAMP

    MDR report key: 5001040 · Received August 5, 2015

    Report

    Report Number
    3009124963-2015-00022
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 1, 2015
    Report Date
    August 5, 2015
    Manufacturer
    CORPAK MEDSYSTEMS
    Product Code
    KNT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    2

    Narratives

    Additional Manufacturer Narrative · 1

    NO SAMPLE WAS RETURNED FOR INVESTIGATION. THE CUSTOMER REPORTED THE PATIENT WAS AT RISK OF CHOKING BECAUSE THE CLAMP WAS REMOVED BY THE CHILD AND FOUND IN THE CHILD'S MOUTH. NO PATIENT INJURY ACTUALLY OCCURRED. CORPAK DOES NOT OFFER A PEG KIT CONTAINING A SIDE LOADING CLAMP. RETENTION SAMPLES OF A SIDE LOADING CLAMP WERE REVIEWED WITH 12 FRENCH PEG TUBING. DUE TO THE CLAMPS BEING USED TO REPLACE THE ORIGINAL CLAMP, THEY ARE DESIGNED TO BE PLACED AND REMOVED FROM THE TUBING. SIDE LOADING CLAMPS ARE AVAILABLE SEPARATELY AS A CONVENIENCE TO THE CUSTOMER.

    Description of Event or Problem · 1

    THE CLAMP FROM THE GASTROSTOMY TUBE WAS REMOVED BY A CHILD PATIENT AND FOUND IN HIS MOUTH, THE PARENTS REPORTED A "NEAR ASPIRATION" TO HIS PUBLIC HEALTH NURSE WHO INFORMED THE HOSPITAL. THE CORFLO PEG TUBE WAS IN SITU FOR 2 YEARS. THE CLAMP SUPPLIED WITH EACH NEW PEG TUBE IS THREADED OVER THE TUBING AND CANNOT BE REMOVED WITHOUT OPENING THE Y FIXATOR. THESE DETERIORATE AND CANNOT BE ORDERED AS REPLACEMENT. THE SIDE LOADING CLAMP WAS GIVEN AS AN ALTERNATIVE TO REPLACING THE ENTIRE PEG. THE CHILD REMOVED THE SIDE LOADING CLAM AND IT WAS FOUND IN HIS MOUTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518907 SIDE LOADING CLAMP KNT CORPAK MEDSYSTEMS 090120039 68462

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Other