BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 17673856 · Received September 1, 2023

    Report

    Report Number
    8041187-2023-00469
    Event Type
    Malfunction
    Date Received
    September 1, 2023
    Date of Event
    August 17, 2023
    Report Date
    September 22, 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

    E.1. INITIAL REPORTER PHONE #: (B)(6). H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS HAVE BEEN UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL?: YES. D.9. RETURNED TO MANUFACTURER ON: 04-SEP-2023. H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 3113666. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY A SAMPLE WAS OBTAINED FOR EVALUATION AND TESTING. FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED UNIT. TESTING RESULTS WERE UNABLE TO DETECT ANY DEVIATION FROM PRODUCT SPECIFICATIONS, AND THE DEVICE RETRACTED NORMALLY WITHOUT INCIDENT. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. COMPLAINTS RECEIVED FOR THIS PRODUCT AND CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE NEEDLE WOULD NOT DISENGAGE. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: WHEN USING AN INDWELLING NEEDLE ON A PATIENT, THE STYLET CANNOT BE WITHDRAWN.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM THE NEEDLE WOULD NOT DISENGAGE. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: WHEN USING AN INDWELLING NEEDLE ON A PATIENT, THE STYLET CANNOT BE WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2224372 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 3113666

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown