BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    URINARY DRAINAGE BAGS

    MDR report key: 3921505 · Received June 9, 2014

    Report

    Report Number
    3005778470-2014-00035
    Event Type
    Malfunction
    Date Received
    June 9, 2014
    Date of Event
    June 21, 2013
    Report Date
    May 13, 2014
    Manufacturer
    UNOMEDICAL S.R.O.
    Product Code
    KNX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 NO LOT NUMBER IS AVAILABLE AND ON THE URINE BAG ARE TWO FIGURES "10, 12" GRAVED. ADDITIONAL INFORMATION WAS RECEIVED VIA EMAIL ON (B)(4) 2014 INFORMING THE PRODUCT WAS USED BY THE PATIENT; DEFECT WAS NOTICED DURING USE; PATIENT REQUIRED NO MEDICAL TREATMENT; EVENT DID NOT RESULT IN ANY SERIOUS INJURY, HOSPITALIZATION, DISABILITY, PERMANENT INJURY OR DEATH TO PATIENT; PATIENT'S MEDICAL HEALTH WAS REPORTED AS GOOD; EVENT OCCURRED DURING CATHETERIZATION AND NO INFORMATION PROVIDED ON WHETHER THE DEVICE WAS REMOVED OR DISCONTINUED. A QUALITY EVALUATION WAS PERFORMED ON (B)(4) 2014. RECEIVED AND EVALUATED WAS ON CONTAMINATED SAMPLE. THE REPORTED FAILURE WAS CONFIRMED BY VISUAL INSPECTION. THE SAMPLE DID NOT MEET THE REQUIREMENTS. LOT NUMBER HAS NOT BEEN PROVIDED BY CUSTOMER THEREFORE DEVICE HISTORY RECORDS OF MANUFACTURING PROCESS CANNOT BE CHECK AND INVESTIGATION PROCESS HAS BEEN PERFORMED BASED ON THE HISTORY RECORDS OF PRODUCT REFERENCE CODE AND FAILURE IN MENTION. NO INCREASING TREND ASSOCIATED WITH PRODUCT REFERENCE CODE AND FAILURE IN MENTION HAS BEEN REGISTERED WITHIN LAST 24 MONTHS. ROOT CAUSE ANALYSIS SHOWED THAT THE DEFECT WAS PROBABLY OCCURRED DURING THE INTERRUPTION OF MACHINE CYCLE DURING PRODUCTION PROCESS AT THE MACHINE. BASED ON THE INFORMATION RECEIVED AND INVESTIGATION FINDINGS THIS FAILURE IS CONSIDERED TO BE ISOLATED WITH LOW OCCURRENCE. NO FURTHER CORRECTIVE ACTION IS REQUIRED. THE FAILURE IS INCLUDED IN RELEVANT RISK MANAGEMENT FILE AND ASSOCIATED HAZARD IS EVALUATED THERE. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. REPORTED TO THE FDA ON (B)(4), 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED "THE CONNECTION TUBE GOT OFF THE URINE BAG COMPLETELY DURING CATHETERIZATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334310 URINARY DRAINAGE BAGS COLLECTOR, URINE, (AND ACCESSORIES) KNX UNOMEDICAL S.R.O. 30 017 0 - LIPA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1