BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODA BALLOON CATHETER

    MDR report key: 6969829 · Received October 23, 2017

    Report

    Report Number
    1820334-2017-03495
    Event Type
    Malfunction
    Date Received
    October 23, 2017
    Date of Event
    October 6, 2017
    Report Date
    March 5, 2018
    Manufacturer
    COOK INC
    Product Code
    DQY
    UDI-DI
    00827002237735
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K122917. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE QC SPECIFICATIONS, DEVICE HISTORY RECORD FOR THE LOT NUMBER INVOLVED WAS REVIEWED. THERE WAS ONE NON CONFORMANCE NOTED FOR FOREIGN MATTER IN THE PACKAGING SEAL, WHICH WAS REWORKED. A COMPLAINT SEARCH REVEALED THIS COMPLAINT TO BE THE ONLY REPORTED COMPLAINT ASSOCIATED TO THE COMPLAINT LOT NUMBER 7853508. RETRAINING WAS CONDUCTED, DUE TO THE HAIR INSIDE THE PRIMARY PACKAGE WHICH WAS OBSERVED DURING INSPECTION AT THE DISTRIBUTION FACILITY. MANUFACTURING RELATED/FOREIGN MATTER HAS BEEN DETERMINED AS THE ROOT CAUSE. WE WILL NOTIFY THE APPROPRIATE PERSONNEL AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADVERSE EVENTS ON PATIENT WAS NOTICED DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 1

    THE DISTRIBUTOR REPORTED THAT DURING INSPECTION OF THE CODA BALLOON CATHETER IT WAS OBSERVED THAT THERE WAS A HAIR INSIDE THE PRIMARY PACKAGE. THIS PRODUCT WAS NOT USED ON A PATIENT. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749826 CODA BALLOON CATHETER DQY CATHETER, PERCUTANEOUS DQY COOK INC G23773 00827002237735

    Patients

    Seq Age Sex Outcome Treatment
    1