BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE¿ PERIPHERAL VENOUS CATHETER

    MDR report key: 7353715 · Received March 20, 2018

    Report

    Report Number
    2243072-2018-00155
    Event Type
    Malfunction
    Date Received
    March 20, 2018
    Date of Event
    March 7, 2018
    Report Date
    March 22, 2018
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    K151698
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED FOR THE MEDICAL DEVICE CAT #(S).  THE FOLLOWING FIELD(S) HAVE BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED DURING USE OF THE BD INSYTE¿ PERIPHERAL VENOUS CATHETER THERE WAS AN ISSUE WITH THE INTEGRITY OF THE TIP AS ¿THE CATHETER SEEMED TO BE BURRING WHEN ADVANCED AND WOULD NOT SEAT CORRECTLY WHEN TRYING TO REPOSITION AND ADVANCE AGAIN.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION. MEDICAL DEVICE BRAND NAME: BD INSYTE¿ PERIPHERAL VENOUS CATHETER. MEDICAL DEVICE CAT #: 381223. UDI: 00382903812233. PMA/510K: K151698.

    Description of Event or Problem · 0

    IT WAS REPORTED DURING USE OF THE BD INSYTE¿ PERIPHERAL VENOUS CATHETER THERE WAS AN ISSUE WITH THE INTEGRITY OF THE TIP AS ¿THE CATHETER SEEMED TO BE BURRING WHEN ADVANCED AND WOULD NOT SEAT CORRECTLY WHEN TRYING TO REPOSITION AND ADVANCE AGAIN.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Additional Manufacturer Narrative · 1

    THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS. AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INVESTIGATION: A SAMPLE IS NOT AVAILABLE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED AS A LOT NUMBER WAS NOT PROVIDED FOR THIS INCIDENT. WITHOUT A SAMPLE, AN ABSOLUTE ROOT CAUSE FOR THIS INCIDENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING USE OF AN UNSPECIFIED INSYTE CATHETER THERE WAS AN ISSUE WITH THE INTEGRITY OF THE TIP AS ¿THE CATHETER SEEMED TO BE BURRING WHEN ADVANCED AND WOULD NOT SEAT CORRECTLY WHEN TRYING TO REPOSITION AND ADVANCE AGAIN.¿ THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195437 BD INSYTE¿ PERIPHERAL VENOUS CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Other