BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3141214 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14023
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 8, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. THE CAUSE OF THIS PERITONITIS WAS USE ERROR DESCRIBED AS A BREAK IN ASEPTIC TECHNIQUE. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT MADE A MISTAKE/ TOUCH CONTAMINATION AND DID NOT WEAR MASK WHILE PERFORMING PERITONEAL DIALYSIS (PD) THERAPY WITH UNKNOWN BAXTER DISPOSABLES. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. PD THERAPY WAS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243704 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other DIANEAL PD4 AMBUFLEX 2.5% AND 4.25%| DIANEAL PD4 ULTRABAG 4.25%