BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD ANGIO CATH

    MDR report key: 3111353 · Received May 9, 2013

    Report

    Report Number
    2243072-2013-00052
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 23, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BD
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SAMPLE HAS NOT BEEN RECEIVED AND A ROOT CAUSE HAS NOT BEEN DETERMINED. IF A SAMPLE ARRIVES FOR INVESTIGATION, A SUPPLEMENTAL WILL BE COMPLETED AND POTENTIAL ROOT CAUSE WILL BE DETERMINED. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE FIRST RELATED COMPLAINT REPORTED FOR THE DEFECT/CONDITION ON LOT NUMBER 8360985.

    Description of Event or Problem · 1

    THE REPORTER STATED THAT ON (B)(6) 2013, THE REPORTER STATED THAT THEY HAD A CATHETER BREAK OFF IN THE PATIENT WHEN THEY DISCONTINUED THE ANGIO CATHETER. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2013 VIA EMAIL FROM THE REPORTER WHICH STATED THAT ON (B)(6) 2013, THERE WAS AN LONGITUDINAL EXCISION PERFORMED IN THE OPERATING ROOM. THE PATIENT CONTINUES IN THE HOSPITAL FOR AN EVENT UNRELATED TO A BD PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202674 BD ANGIO CATH 20G X 1.88IN FOZ BD 8360985

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention