BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS YEL 24GAX0.75IN PRN-CAPY

    MDR report key: 12824317 · Received November 16, 2021

    Report

    Report Number
    3014704491-2021-00265
    Event Type
    Malfunction
    Date Received
    November 16, 2021
    Date of Event
    October 19, 2021
    Report Date
    November 22, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL?: YES. D9: RETURNED TO MANUFACTURER ON: 11/15/2021. H6: INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1152551. 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 RETURNED TO AID IN OUR INVESTIGATION. OUR ENGINEERS SUBJECTED THE DEVICE TO LEAKAGE TESTING AND FOUND THE DEVICE TO OPERATE NORMALLY, DETECTING TO SIGNS OF LEAKAGE, FLOW RATE OBSTRUCTIONS, OR OTHER ABNORMALITIES. UNFORTUNATELY WITH OUT THE ABILITY TO OBSERVE THE REPORTED FAILURE MODE, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PEGASUS YEL 24GAX0.75IN PRN-CAPY THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE HEAD NURSE OF INTERNAL MEDICINE GAVE FEEDBACK THAT THE SEPTUM OF INDWELLING NEEDLE WOULD LEAK WHEN DISENGAGING THE NEEDLE AFTER PUNCTURE."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD PEGASUS YEL 24GAX0.75IN PRN-CAPY THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE HEAD NURSE OF INTERNAL MEDICINE GAVE FEEDBACK THAT THE SEPTUM OF INDWELLING NEEDLE WOULD LEAK WHEN DISENGAGING THE NEEDLE AFTER PUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716634 BD PEGASUS YEL 24GAX0.75IN PRN-CAPY CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1152551

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown