BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CPK CORFLO WITH STYLET

    MDR report key: 6616086 · Received June 6, 2017

    Report

    Report Number
    3009124963-2017-00023
    Event Type
    Malfunction
    Date Received
    June 6, 2017
    Date of Event
    April 29, 2017
    Report Date
    May 9, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    FPD
    UDI-DI
    20815149023858
    PMA / PMN Number
    K083210
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    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 02-JUN-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 COMP-(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 A HALYARD HEALTH PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 1

    HALYARD RECEIVED A SINGLE REPORT THAT REFERENCED 2 DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THE SAME PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 3009124963-2017-00024 FOR THE SECOND EVENT. A REPORT WAS RECEIVED STATING THE TUBE IS FLAKING. THE FLAKING FRAGMENTS WERE NOTED IN THE PATIENT'S FECES. THE PARENT REPORTS USING VASELINE AT THE TIP OF THE DEVICE FOR INSERTION OF THE TUBE. THERE WAS NO REPORTED INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396662 CPK CORFLO WITH STYLET DH CPK ANTI-IV (AIV) FEEDING TUBES FPD HALYARD HEALTH 20-9366AIV2 UNKNOWN 20815149023858

    Patients

    Seq Age Sex Outcome Treatment
    1 16 MO