BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 22GA X 1IN PRN

    MDR report key: 17878710 · Received October 5, 2023

    Report

    Report Number
    8041187-2023-00522
    Event Type
    Malfunction
    Date Received
    October 5, 2023
    Date of Event
    September 20, 2023
    Report Date
    November 7, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS AN OUTGOING INSPECTION AS PER MQA-069/C TO CHECK FOR FM, THERE IS NO QN RAISED FOR FM DURING THE PRODUCTION OF THIS BATCH. NO PHOTO / SAMPLE IS RECEIVED. IF THERE IS A SAMPLE RECEIVED, THE FM ON THE SAMPLE CAN BE INVESTIGATED TO DETERMINE ITS CAUSE. THE COMPLAINT WILL BE RE-OPENED WHEN THERE IS A SAMPLE RECEIVED FOR THIS COMPLAINT. THE COMPLAINT TREND WILL BE TRACKED AND MONITORED. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    THE NURSE INTENDS TO USE THE INDWELLING NEEDLE TO ESTABLISH VENOUS ACCESS TO THE PATIENT. DURING THE PRE-USE EXAMINATION, FOREIGN BODIES ARE FOUND OUTSIDE THE CANNULA OF THE INDWELLING NEEDLE, AND THE RESIDUE OF SIMILAR CANNULA MATERIALS SHOULD BE REPLACED IMMEDIATELY.NO HARM TO PATIENTS WITHOUT USE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD PEGASUS YEL 22GA X 1IN PRN FOREIGN MATTER WAS FOUND. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE NURSE INTENDS TO USE THE INDWELLING NEEDLE TO ESTABLISH VENOUS ACCESS TO THE PATIENT. DURING THE PRE-USE EXAMINATION, FOREIGN BODIES ARE FOUND OUTSIDE THE CANNULA OF THE INDWELLING NEEDLE, AND THE RESIDUE OF SIMILAR CANNULA MATERIALS SHOULD BE REPLACED IMMEDIATELY NO HARM TO PATIENTS WITHOUT USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2010695 BD PEGASUS YEL 22GA X 1IN PRN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 2175573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown