BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5F ULTIMUM INTRODUCER BULK NON STERILE

    MDR report key: 2010817 · Received March 2, 2011

    Report

    Report Number
    2182269-2011-00033
    Event Type
    Injury
    Date Received
    March 2, 2011
    Date of Event
    February 10, 2011
    Report Date
    March 2, 2011
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT WAS RETURNED FOR ANALYSIS AS THE HOSP IS RETAINING THE PRODUCT. THE EXACT LOT NUMBER WAS UNK; HOWEVER, THE DISTRIBUTOR REPORTED THAT THE PRODUCT WAS FROM ONE OF TWO LOTS, 3166727 OR 3235283. REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THE SUBJECT LOTS (3166727 AND 3235283) BOTH MET MFG REQUIREMENTS PRIOR TO SHIPMENT. THE MFG AND USE BY/BEFORE DATE ARE AS FOLLOWS: LOT 3166727: MFG DATE: (B)(4) 2010; USE BY/BEFORE DATE: NA. LOT 3235283: MFG DATE: (B)(4) 2010; USE BY/BEFORE DATE: NA.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DISTRIBUTOR THAT A CUSTOMER REPORTED THAT DURING A PROCEDURE THE 5F ULTIMUM INTRODUCER WAS USED. DURING THE EXCHANGE OF THE GUIDEWIRE AT REMOVAL OF THE GUIDEWIRE THE SHEATH WAS TORN OFF. THE REMAINING PART OF THE SHEATH WAS REMOVED BY SURGICAL INTERVENTION. THE PT'S HOSPITALIZATION WAS EXTENDED DUE TO THE ADDITIONAL SURGICAL INTERVENTION BUT NO HEALTH IMPAIRMENT WAS EXPERIENCED. THIS IS A BULK NON-STERILE PRODUCT PACKAGED AND DISTRIBUTED BY (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 5F ULTIMUM INTRODUCER BULK NON STERILE BULK NON STERILE INTRODUCER DYB ST. JUDE MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R