BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL/BIOFLO

    MDR report key: 4170241 · Received October 1, 2014

    Report

    Report Number
    1317056-2014-00060
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 19, 2014
    Report Date
    September 4, 2014
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K133264
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN LIEU OF A REPORTED LOT NUMBER, A SHIP HISTORY REPORT (SHR) WAS GENERATED IN ORDER TO ASCERTAIN THE LAST THREE LOTS SHIPPED TO THE REPORTING HOSPITAL IN THE SIX MONTHS PRIOR TO THE PROCEDURE DATE. TWO LOTS WERE OBTAINED. THE DEVICE HISTORY RECORDS FOR THE LOTS OBTAINED THROUGH THE SHIP HISTORY REPORT WERE REVIEWED FOR THE INDICATED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE (B)(6) 2014 (B)(6) MEDICAL COMPLAINT REPORT WAS PERFORMED FOR THE BIOFLO PICC PRODUCT FAMILY FOR THE FAILURE MODE "GUIDEWIRE FRACTURED/MIGRATED." NO ADVERSE TRENDS WERE IDENTIFIED. THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED AS NO SAMPLE WAS RETURNED FOR EVALUATION. THE GUIDEWIRE IS SUPPLIED TO (B)(6) MEDICAL BY LAKE REGION MANUFACTURING, AND THEY HAVE BEEN NOTIFIED OF THIS EVENT VIA SUPPLIER CORRECTIVE ACTION REQUEST FOR INFORMATIONAL PURPOSES. POTENTIAL CONTRIBUTING FACTORS TO THE GUIDEWIRE FRACTURE COULD BE PATIENT ANATOMY, OR IF THE GUIDEWIRE WAS PULLED BACK AGAINST A NEEDLE, AN EVENT CAUTIONED AGAINST IN THE DIRECTIONS FOR USE WHICH IS PACKAGED WITH THE PICC DEVICE. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED: PHYSICIAN WAS PERFORMING A STANDARD PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) PROCEDURE, MOVING THE GUIDEWIRE, PACKAGED WITH THE BIOFLO PICC THROUGH THE AUXILLIARY VEIN, WHEN THE FLOPPY TIP OF THE GUIDEWIRE SEVERED FROM THE STAINLESS STEEL MANDRIL PORTION OF THE WIRE. ALL WIRE PIECES WERE REMOVED FROM THE BODY AND THE PATIENT WAS NOT HARMED. AN ALTERNATIVE PICC DEVICE WAS THEN PLACED. THE USED GUIDEWIRE WAS DISCARDED AT THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610200 NAVILYST MEDICAL/BIOFLO PERIPHERALLY INSERTED CENTRAL CATHETER LJS NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention