BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS Y 20GA X 1.16IN SS PRN NPVC

    MDR report key: 15829476 · Received November 18, 2022

    Report

    Report Number
    3014704491-2022-00592
    Event Type
    Malfunction
    Date Received
    November 18, 2022
    Date of Event
    October 20, 2022
    Report Date
    November 26, 2022
    Manufacturer
    BD (SUZHOU)
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050856. 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. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE #: (B)(4). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS Y 20GA X 1.16IN SS PRN NPVC AUTOMATICALLY REBOUNDED, CAUSING THE PATIENT TO OOZE BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE IN THE HEPATOBILIARY SURGERY INFUSES THE PATIENT, AFTER THE INFUSION IS COMPLETED, THE END OF THE POSITIVE PRESSURE HEPARIN CAP OF THE CLOSED NEEDLE STICK-PROOF VENOUS INDWELLING NEEDLE WILL AUTOMATICALLY REBOUND, CAUSING THE PATIENT TO OOZE BLOOD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS Y 20GA X 1.16IN SS PRN NPVC AUTOMATICALLY REBOUNDED, CAUSING THE PATIENT TO OOZE BLOOD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: WHEN THE NURSE IN THE HEPATOBILIARY SURGERY INFUSES THE PATIENT, AFTER THE INFUSION IS COMPLETED, THE END OF THE POSITIVE PRESSURE HEPARIN CAP OF THE CLOSED NEEDLE STICK-PROOF VENOUS INDWELLING NEEDLE WILL AUTOMATICALLY REBOUND, CAUSING THE PATIENT TO OOZE BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1761643 BD PEGASUS Y 20GA X 1.16IN SS PRN NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 1050856

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown