BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BARD URINARY 2 LITER DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

    MDR report key: 4454772 · Received December 16, 2014

    Report

    Report Number
    1018233-2014-00354
    Event Type
    Malfunction
    Date Received
    December 16, 2014
    Date of Event
    December 13, 2014
    Report Date
    December 13, 2014
    Manufacturer
    PRODUCTOS PARA EL CUIDADO DE LA SALUD
    Product Code
    KNX
    PMA / PMN Number
    EXEMPT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS NOT ASSOCIATED WITH A CUSTOMER COMPLAINT OR REPORTED ADVERSE EVENT; HOWEVER, IT IS BEING FILED IN ACCORDANCE WITH 21 CFR PART 803.53. INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BARD MEDICAL DIVISION (BMD) WAS NOTIFIED BY THE (B)(4) MANUFACTURING SITE THAT DURING BARD 100% LATEX-FREE URINARY DRAINAGE BAG INSPECTION, THEY FOUND HOLES/TEARS IN THE PACKAGING TYVEK THAT LEAKED WHEN CHALLENGED WITH BLUE DYE WATER. THE SUBJECT PRODUCT IS SOLD STERILE. ON (B)(6) 2014 IT WAS CONFIRMED THAT IT IMPACTED THIS LOT RELEASED INTO DISTRIBUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    825315 BARD URINARY 2 LITER DRAINAGE BAG WITH ANTI-REFLUX CHAMBER KNX PRODUCTOS PARA EL CUIDADO DE LA SALUD NA NGYJ0603

    Patients

    Seq Age Sex Outcome Treatment
    1