BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3F SILICONE BD FIRST PICC

    MDR report key: 560469 · Received December 8, 2004

    Report

    Report Number
    560469
    Event Type
    Malfunction
    Date Received
    December 8, 2004
    Date of Event
    August 27, 2004
    Report Date
    December 8, 2004
    Manufacturer
    B-D
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A 3F SILICONE B-D FIRST PICC WAS PLACED IN PATIENT. SHORTLY AFTER INSERTION PATIENT DEVELOPED ABDOMINAL PAIN, SHORTNESS OF BREATH AND TOTAL BODY RASH. PICC WAS PULLED AND SYMPTOMS RESOLVED AFTER 10 MINUTES. POLYURETHANE PICC PLACED NEXT DAY IN RADIOLOGY. FOLLOW-UP REVEALS: ADDITIONAL DETAILS PROVIDED BY SITE REPORTER IN RESPONSE TO ANALYST FOLLOW UP QUESTIONS. THE PICC CATHETERS WERE INSERTED BY NURSES AND THEIR EXPERIENCE RANGE FROM 5 YEARS OR GREATER. ONE IS CRNI CERTIFIED, THE OTHER 2 HAVE 20 CEU CREDITS ON PICC INSERTION. THEY HAVE INSERTED 130-160 PICCS PER MONTH AND HAVE TAKEN NEONATAL COURSES. THE PICC KIT DOES NOT CONTAIN GLOVES, LATEX GLOVES WITH POWDER WERE USED. THE PATIENT HAS NO KNOWN ALLERGIES TO LATEX. THERE WERE NO UNUSUAL PRE-PICC INSERTION PATIENT CONDITIONS NOTED EXCEPT ANXIETY. THE SAME SIZE PICC IS INSERTED INTO ADULTS OR CHILDREN. THE SITE INFORMED THE MFR AND THEY SENT A LETTER ACKNOWLEDGING THE EVENTS. THIS LETTER WILL BE FAXED TO THE FDA WHEN IT IS RECEIVED FROM THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3F SILICONE BD FIRST PICC PICC DQO B-D * *

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR