BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10804707 · Received November 6, 2020

    Report

    Report Number
    3006948883-2020-00718
    Event Type
    Malfunction
    Date Received
    November 6, 2020
    Date of Event
    October 14, 2020
    Report Date
    December 14, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    NGT
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: (B)(6) 2020. H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0063013. 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 THE SAMPLE SUBMITTED TO OUR FACILITY WAS SUBJECTED TO FUNCTIONAL TESTING AND MICROSCOPIC VISUAL ANALYSIS. THE RESULTS OF THESE TESTS SHOW THAT THE SUBMITTED DEVICE PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE ADAPTER SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE CT ROOM NURSE INDWELLING THE PATIENT WITH 20G STRAIGHT PEGASUS IN THE MIDDLE OF THE ELBOW. AFTER REMOVING THE NEEDLE , THERE WAS BLOOD LEAKAGE AT THE END OF THE SEPTUM. THE EXAMINATION COULD BE COMPLETED NORMALLY

    Additional Manufacturer Narrative · 1

    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 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE ADAPTER SEPTUM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE CT ROOM NURSE INDWELLING THE PATIENT WITH 20G STRAIGHT PEGASUS IN THE MIDDLE OF THE ELBOW. AFTER REMOVING THE NEEDLE , THERE WAS BLOOD LEAKAGE AT THE END OF THE SEPTUM. THE EXAMINATION COULD BE COMPLETED NORMALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262701 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM SALINE, VASCULAR ACCESS FLUSH NGT BD (SUZHOU) UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1