BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3092782 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11294
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Report Date
    April 8, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE REPORTED PROBLEM OF A DAMAGED MINICAP WAS CONFIRMED THROUGH A SAMPLE EVALUATION. VISUAL INSPECTION OF THE USED SAMPLE REVEALED THE MINICAP WAS CRACKED AT THE KNIT LINE, ON THE SURFACE OF THE CAP. THE SURFACE CRACK APPEARED WHEN THE MINICAP WAS SQUEEZED FROM BOTH SIDES. PRESSURE TESTING WAS PERFORMED WITH NO LEAKS DETECTED. IT WAS POSSIBLE THAT THE CRACK OCCURRED DUE TO OVER-TIGHTENING OF THE MINICAP ON THE TRANSFER SET, HOWEVER A DEFINITIVE CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    FOUR MINICAPS WERE RECEIVED FROM A CUSTOMER AND IT WAS REPORTED THE MINICAPS HAD SPLITS. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194864 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1