BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISP SNAP Y SET, W/DISINFECT, W/DR BAG

    MDR report key: 157742 · Received March 16, 1998

    Report

    Report Number
    1713747-1998-00658
    Event Type
    Injury
    Date Received
    March 16, 1998
    Date of Event
    February 1, 1998
    Report Date
    February 19, 1998
    Manufacturer
    MEDISYSTEMS
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    FACILITY RN REPORTED THE PT HAS EXPERIENCED MANY DIFFICULTIES WITH THE DEL-CLAMP SINCE 12/97. AFTER APPLYING THE CLAMP, THE SOLUTION CONTINUED TO FLOW. WILL GET A RECORD REVIEW OF ALL LOT NUMBERS PT HAS REC'D SINCE 11/97 (LOT # FOR THIS PIR IS 7103012). PT IS ON ANTIBIOTICS, HOWEVER ALL CULTURES ARE NEGATIVE. FOUR USED SAMPLES ARE AVAILABLE FOR EXAMINATION AS WELL AS 1/2 CASE OF UNUSED SAMPLES. [ADDITIONAL LOT NUMBERS TO BE REVIEWED 7083013, 7113003: THESE WERE THE FIVE LOT NUMBERS DELIVERED TO THE PT SINCE 11/97].

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISP SNAP Y SET, W/DISINFECT, W/DR BAG CLAMP ON THE TUBING OF THE PD SET KDJ MEDISYSTEMS * SEE BELOW

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other| R NONE, NONE