BEUDAMED
    FDA Adverse Event Injury Summary report: N

    12 FOOT EXTENSION SET EASYLOCK CONNECTOR

    MDR report key: 1790320 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02320
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).SAMPLE NOT AVAILABLE AS PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOMECHOICE PATIENT (HP) WHO REQUESTED TECHNICAL ASSISTANCE ON (B)(6) 2010. HP REQUESTED ASSISTANCE IN ENDING THERAPY IN ORDER TO GO TO THE HOSPITAL. THIS WAS DURING PATIENT USE. TECHNICAL SERVICE REPRESENTATIVE WAS ABLE TO ASSIST HP WITH A SOLUTION OVER THE PHONE. ON (B)(6) 2010, PRODUCT SURVEILLANCE CONTACTED THE PERITONEAL DIALYSIS (PD) NURSE REGARDING HOME PATIENT GOING TO THE HOSPITAL. THE NURSE STATED THAT THE PATIENT HAD PERITONITIS. SHE STATED SHE DID NOT KNOW THE CAUSE OF THE PERITONITIS AND WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION. THIS IS COMPLAINT FOUR OF FOUR RELATED COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 12 FOOT EXTENSION SET EASYLOCK CONNECTOR SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%?