BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3092612 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11266
    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). THE LOT NUMBER WAS UNKNOWN; THEREFORE A BATCH REVIEW COULD NOT BE PERFORMED. THE REPORTED PROBLEM OF DAMAGED MINICAP WAS CONFIRMED THROUGH 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 ONLY APPEARED WHEN THE MINICAP WAS SQUEEZED FROM BOTH SIDES OR BY OVER-TIGHTENING THE MINICAP ONTO THE LUER OF A TRANSFER SET. PRESSURE TESTING WAS PERFORMED WITH NO LEAKS DETECTED. IT WAS DETERMINED THE ROOT CAUSE OF THE CRACKED/DAMAGED MINICAP WAS POSSIBLY FROM THE USER EITHER EXCESSIVELY SQUEEZING ON BOTH SIDES OF THE MINICAP OR OVER-TIGHTENING THE MINICAP ONTO THE LUER OF THE TRANSFER SET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME 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. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. NO ADDITIONAL INFORMATION WAS PROVIDED. THIS IS REPORT 3 OF 4 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194685 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1