BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINICAP

    MDR report key: 3092986 · Received May 3, 2013

    Report

    Report Number
    1416980-2013-11333
    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 CONDITION WAS CONFIRMED THROUGH A SAMPLE EVALUATION. VISUAL INSPECTION OF THE USED SAMPLE REVEALED THAT 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. ADDITIONAL INFORMATION: A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MINICAP HAD CRACKED. A CUSTOMER RETURNED 6 USED MINICAPS FOR FURTHER EVALUATION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THIS IS REPORT 5 OF 6 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194834 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND GD892364

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE| TRANSFER SET