BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHY-CLOSED S.CH14 25CM/78

    MDR report key: 3908226 · Received May 30, 2014

    Report

    Report Number
    3007966929-2014-00017
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    UNOMEDICAL LTD.
    Product Code
    BZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. IT WAS FURTHER REPORTED THE "HOSPITAL IS CONCERNED WITH INFECTION." ADDITIONAL EVENT INFORMATION WAS PROVIDED VIA EMAIL ON (B)(4) 2014 INFORMING THAT THEY REPLACED THE DEVICE DUE TO THE CONTINUED ISSUES WITH SLEEVE INFLATION AND MOISTURE BUILD-UP. NO INFORMATION WAS PROVIDED OR REPORTED THAT ANY INFECTIONS HAD OCCURRED TO PATIENT(S); THEY FURTHER INFORMED THAT THEY CANNOT DETERMINE EXACT NUMBER OF PATIENT(S) INVOLVED AND THE PRODUCT WAS USED IN THE SURGICAL INTENSIVE CARE UNIT. THEY WENT ON TO INFORM THAT IT IS UNKNOWN HOW LONG THE PRODUCT WAS IN USE PRIOR TO THE EVENT OCCURRING. ISSUES OCCURRED ON FIVE (5) SEPARATE CASES. A SEPARATE 3500A FORM HAS BEEN COMPLETED FOR THE OTHER (4) CASES UNDER PATIENT IDENTIFIER(S) (B)(6). MFR REPORTS #: 3007966929-2014-00019, 00021, 00023 AND 00025 RESPECTIVELY. (REPORT 1 OF 5) NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED. NOTE: THE ACTUAL DATE OF EVENT IS UNKNOWN, SO THE DATE USED WAS THE DATE CONVATEC BECAME AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED "INFLATION OF CATHETER SLEEVE (MAKING IT DIFFICULT TO MANIPULATE THE CATHETER DUE TO THE AIR PRESSURE); MOISTURE BUILD-UP INSIDE THE SLEEVE." NOTE: THIS REPORTED ISSUE OCCURRED ON FIVE SEPARATE CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319811 CATHY-CLOSED S.CH14 25CM/78 CATHETER, NASAL, OXYGEN BZB UNOMEDICAL LTD. 36047182 635441

    Patients

    Seq Age Sex Outcome Treatment
    1