BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10243255 · Received July 8, 2020

    Report

    Report Number
    8041187-2020-00391
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 16, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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 WERE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. DHR WAS PERFORMED. ONE RELATED TD WAS FOUND, TD 2018-45. THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM HAD A DEFORMED SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE PREOPERATIVE PREPARATION FOR THE PATIENT, THE INDWELLING NEEDLE WAS EXAMINED BEFORE THE INDWELLING NEEDLE PUNCTURING, AND IT WAS FOUND THAT THERE WAS NO HOLE FOR DRUG FLOW IN THE SEPTUM OF THE INDWELLING NEEDLE ".

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM HAD A DEFORMED SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE PREOPERATIVE PREPARATION FOR THE PATIENT, THE INDWELLING NEEDLE WAS EXAMINED BEFORE THE INDWELLING NEEDLE PUNCTURING, AND IT WAS FOUND THAT THERE WAS NO HOLE FOR DRUG FLOW IN THE SEPTUM OF THE INDWELLING NEEDLE "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    712783 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 8332679

    Patients

    Seq Age Sex Outcome Treatment
    1 Other