BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STAY SAFE/LUER LOCK CATHETER EXT. 12 IN

    MDR report key: 3874965 · Received June 2, 2014

    Report

    Report Number
    8030665-2014-00454
    Event Type
    Injury
    Date Received
    June 2, 2014
    Date of Event
    March 21, 2014
    Report Date
    May 1, 2014
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    FKX
    PMA / PMN Number
    K822543
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION PROVIDED, IT IS UNKNOWN HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF PLANT'S INVESTIGATION.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS NURSE REPORTED THE PATIENT WAS HOSPITALIZED ON (B)(6) 2014 WITH A DIAGNOSIS OF PERITONITIS. HE HAD BEEN EXPERIENCING PAIN IN THE RIBS FROM A FALL AT HOME ON (B)(6) 2014, SHORTNESS OF BREATH, AND COMPLAINTS OF "FLUID LEAKING IN HIS ABDOMEN". HE "THOUGHT HE HAD AN INFECTION". NURSE ADVISED PATIENT TO GO TO EMERGENCY ROOM AND PATIENT WAS ADMITTED FOR PERITONITIS AND TREATED WITH ANTIBIOTICS. THE NURSE REPORTED THE CAUSE OF THE PERITONITIS WAS THE PATIENT ACCIDENTALLY DISCONNECTED HIS EXTENSION SET FROM THE DIALYSIS TUBING. PATIENT WAS DISCHARGED ON OR ABOUT (B)(6) 2014 AND FOLLOWED UP WITH DIALYSIS CLINIC FOR FURTHER ANTIBIOTIC ADMINISTRATION. THIS PATIENT IS REPORTED TO BE HAVING INCREASING DIFFICULTY WITH MANAGING HIS PERITONEAL DIALYSIS TREATMENT AT HOME AND HAVING A HISTORY OF FALLS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321096 STAY SAFE/LUER LOCK CATHETER EXT. 12 IN FKX FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R LIBERTY CYCLER| FRESENIUS PERITONEAL DIALYSIS SOLUTION| LIBERTY CASSETTE