BEUDAMED
    FDA Adverse Event Other Summary report: N

    3 PRONG ECO SET W/2 PREFILLED CONNECTORS

    MDR report key: 99257 · Received June 18, 1997

    Report

    Report Number
    1713747-1997-00464
    Event Type
    Other
    Date Received
    June 18, 1997
    Date of Event
    June 12, 1997
    Report Date
    June 18, 1997
    Manufacturer
    FRESENIUS USA
    Product Code
    KPF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MALE/FEMALE CONNECTOR WAS ASSEMBLED UPSIDE DOWN DURING FINAL ASSEMBLY. PT DID NOT DEVELOP PERITONITIS.PIR# 9700435

    Description of Event or Problem · 1

    FACILITY REPORTED THAT WHEN THE HOME PT WENT TO USE THE SET, THE PT CONNECTION END HAD A MALE CONNECTION END INSTEAD OF A FEMALE CONNECTION. THE PT HAD HIS CATHETER EXPOSED FOR AWHILE AND WENT TO THE DIALYSIS CLINIC. THE PT WAS GIVEN PROPHYLACTIC ANTIBIOTICS. THE PT DID NOT DEVELOP PERITONITIS. THE SAMPLE IS AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3 PRONG ECO SET W/2 PREFILLED CONNECTORS PERITONEAL DIALYSIS PRODUCT KPF FRESENIUS USA * 70-230-31

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other