BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3802818 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14985
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    April 6, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED 01/10/2014 - 01/17/2014. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE EVALUATION COULD NOT BE CONDUCTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MINICAP WOULD NOT CONNECT CORRECTLY TO A TRANSFER SET. THE REPORTER STATED THAT THERE WAS AN ¿ISSUE WITH THE THREADS ON [THE MINICAP], IT DID NOT FIT CORRECTLY, IT WAS NOT CLICKING COMPLETELY TIGHT AND WAS THEN LEAKING THE IODINE.¿ THIS OCCURRED DURING PATIENT USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280341 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD896209

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR