BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS GN 18GA X 1.16IN PRN-CAP Y

    MDR report key: 12060599 · Received June 24, 2021

    Report

    Report Number
    3006948883-2021-00704
    Event Type
    Malfunction
    Date Received
    June 24, 2021
    Date of Event
    May 17, 2021
    Report Date
    June 15, 2021
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231281. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS 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. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS GN 18GA X 1.16IN PRN-CAP Y LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AT 8:35 ON (B)(6) 2021, THE PATIENTS WERE ASSIGNED FOR PREOPERATIVE VENIPUNCTURE. AFTER PULLING OUT THE NEEDLE , BLOOD WAS FOUND TO LEAK FROM THE TAIL OF THE INDWELLING NEEDLE, AND FLUID WAS FOUND TO LEAK FROM THE BACK, AND THERE WAS NO SWELLING AND EXUDATION AT THE PUNCTURE SITE, SO THE NEEDLE WAS REMOVED IMMEDIATELY. REPLACE THE INDWELLING NEEDLE AND THE PUNCTURE SITE, AND PUNCTURE AGAIN. THE ESTABLISHMENT OF VENOUS ACCESS WAS COMPLETED AT 8:40.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    955458 PEGASUS GN 18GA X 1.16IN PRN-CAP Y CATHETER FOZ BD (SUZHOU) 0231281

    Patients

    Seq Age Sex Outcome Treatment
    1