BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD PEGASUS IV CATHETER SYSTEM

    MDR report key: 11052333 · Received December 21, 2020

    Report

    Report Number
    2243072-2020-02102
    Event Type
    Malfunction
    Date Received
    December 21, 2020
    Date of Event
    November 14, 2020
    Report Date
    January 20, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRN SEPARATED FROM THE UNSPECIFIED BD PEGASUS¿ IV CATHETER SYSTEM DURING USE AND CAUSED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT 9:00 A.M. ON (B)(6) 2020, DURING THE CTA SCAN FOR THE PATIENT, THE HEPARIN CAP OF THE NO. 20 RED CLOSED ANTI-NEEDLE STAB WOUND INTRAVENOUS INDWERED NEEDLE SUDDENLY FELL OFF, RESULTING IN THE FAILURE OF THE SCAN AND NO INFLUENCE WAS CAUSED TO THE PATIENT."

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). THE REPORTED LOT # 9232320 WAS SEARCHED IN SAP, BUT A CORRESPONDING MATERIAL # MATCHING THE CUSTOMER'S EVENT DESCRIPTION WAS NOT FOUND. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRN SEPARATED FROM THE UNSPECIFIED BD PEGASUS¿ IV CATHETER SYSTEM DURING USE AND CAUSED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT 9:00 A.M. ON (B)(6) 2020, DURING THE CTA SCAN FOR THE PATIENT, THE HEPARIN CAP OF THE NO. 20 RED CLOSED ANTI-NEEDLE STAB WOUND INTRAVENOUS INDWERED NEEDLE SUDDENLY FELL OFF, RESULTING IN THE FAILURE OF THE SCAN AND NO INFLUENCE WAS CAUSED TO THE PATIENT".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511629 UNSPECIFIED BD PEGASUS IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1