BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC

    MDR report key: 12724947 · Received October 30, 2021

    Report

    Report Number
    3014704491-2021-00234
    Event Type
    Malfunction
    Date Received
    October 30, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 31, 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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050699. 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. SEE H10.

    Additional Manufacturer Narrative · 0

    (B)(6). 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 · 0

    IT WAS REPORTED THAT PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC HAD CONNECTION ISSUES AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS OPERATED ON (B)(6) 2021. THE PATIENT WAS GIVEN INDWELLING NEEDLE, THE Y-TYPE CONNECTION SITE TO ACCESS THE CONNECTA IN THE OPERATING ROOM. WHEN THE PATIENT RETURNED TO THE WARD AT 14:00 AFTER SURGERY, THE CONNECTA WAS PRE-REMOVED, BUT IT WAS FOUND THAT THE CONNECTION WAS TOO TIGHT AND COULD NOT BE REMOVED, SO THE CONNECTA WAS NOT FORCIBLY REMOVED. DURING INFUSION OF THE PATIENT, LEAKAGE WERE FOUND AT THE Y-TYPE CONNECTOR SITE DUE TO BROKEN, AND COULD NOT BE USED, SO THE INDWELLING NEEDLE MUST BE REMOVED AND THE PATIENT WAS GIVEN A SECOND PUNCTURE INDWELLING NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC HAD CONNECTION ISSUES AND LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS OPERATED ON (B)(6) 2021. THE PATIENT WAS GIVEN INDWELLING NEEDLE, THE Y-TYPE CONNECTION SITE TO ACCESS THE CONNECTA IN THE OPERATING ROOM. WHEN THE PATIENT RETURNED TO THE WARD AT 14:00 AFTER SURGERY, THE CONNECTA WAS PRE-REMOVED, BUT IT WAS FOUND THAT THE CONNECTION WAS TOO TIGHT AND COULD NOT BE REMOVED, SO THE CONNECTA WAS NOT FORCIBLY REMOVED. DURING INFUSION OF THE PATIENT, LEAKAGE WERE FOUND AT THE Y-TYPE CONNECTOR SITE DUE TO BROKEN, AND COULD NOT BE USED, SO THE INDWELLING NEEDLE MUST BE REMOVED AND THE PATIENT WAS GIVEN A SECOND PUNCTURE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1623076 PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1050699

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown