BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC

    MDR report key: 9689808 · Received February 10, 2020

    Report

    Report Number
    3006948883-2020-00054
    Event Type
    Malfunction
    Date Received
    February 10, 2020
    Date of Event
    January 21, 2020
    Report Date
    February 18, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141632. 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. UNFORTUNATELY DUE TO THE RECENT OUTBREAK OF INFECTIOUS DISEASE, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC HAD A HOLE IN IT AND ALLOWED BLOOD TO FLOW OUT OF THE CATHETER. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE NURSE PLACED AN INDWELLING NEEDLE ON THE PATIENT. DURING THE PUNCTURE, IT WAS FOUND THAT BLOOD FLOWED OUT OF THE CATHETER. THE NURSE PULLED OUT THE INDWELLING NEEDLE AND FOUND A HOLE IN THE CATHETER. THE NEEDLE WAS CONTAMINATED BY THE PATIENT'S BLOOD BECAUSE OF THE PROBLEM, AND THE NEEDLE WAS DISCARDED BY THE OPERATING NURSE. THE OPERATING NURSE DENIED THAT THE NEEDLE CORE WAS LOOSENED UP AND DOWN, SAYING THAT THE PHENOMENON HAD OCCURRED IN 3 CASES.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC HAD A HOLE IN IT AND ALLOWED BLOOD TO FLOW OUT OF THE CATHETER. THIS OCCURRED ON 3 OCCASIONS DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2020, THE NURSE PLACED AN INDWELLING NEEDLE ON THE PATIENT. DURING THE PUNCTURE, IT WAS FOUND THAT BLOOD FLOWED OUT OF THE CATHETER. THE NURSE PULLED OUT THE INDWELLING NEEDLE AND FOUND A HOLE IN THE CATHETER. THE NEEDLE WAS CONTAMINATED BY THE PATIENT'S BLOOD BECAUSE OF THE PROBLEM, AND THE NEEDLE WAS DISCARDED BY THE OPERATING NURSE. THE OPERATING NURSE DENIED THAT THE NEEDLE CORE WAS LOOSENED UP AND DOWN, SAYING THAT THE PHENOMENON HAD OCCURRED IN 3 CASES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154155 PEGASUS PNK 20GAX1.16IN PRN-CAPY NON-PVC N/A FOZ BD (SUZHOU) 9141632

    Patients

    Seq Age Sex Outcome Treatment
    1 Other