BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS PNK 20GA X 1.16IN PRN

    MDR report key: 15911828 · Received December 2, 2022

    Report

    Report Number
    3014704491-2022-00621
    Event Type
    Malfunction
    Date Received
    December 2, 2022
    Date of Event
    May 20, 2022
    Report Date
    December 11, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. 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

    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

    H.6. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050867 . 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE AFFECTED 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS PNK 20GA X 1.16IN PRN EXPERIENCED LEAKAGE AT THE DIAPHRAGM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE INDWELLING NEEDLE IS TIED AND THE STEEL NEEDLE IS WITHDRAWN DURING THE PREPARATION FOR GASTROINTESTINAL ENDOSCOPY, FLUID LEAKAGE OCCURRED. DUE TO THE SEEPAGE OF BLOOD AT THE ISOLATION PLUG, THE INDWELLING NEEDLE HAS BEEN DISCARDED AND CANNOT BE RETURNED TO THE FACTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS PNK 20GA X 1.16IN PRN EXPERIENCED LEAKAGE AT THE DIAPHRAGM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THE INDWELLING NEEDLE IS TIED AND THE STEEL NEEDLE IS WITHDRAWN DURING THE PREPARATION FOR GASTROINTESTINAL ENDOSCOPY, FLUID LEAKAGE OCCURRED. DUE TO THE SEEPAGE OF BLOOD AT THE ISOLATION PLUG, THE INDWELLING NEEDLE HAS BEEN DISCARDED AND CANNOT BE RETURNED TO THE FACTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536344 BD PEGASUS PNK 20GA X 1.16IN PRN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1050867

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown