BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC

    MDR report key: 9589490 · Received January 14, 2020

    Report

    Report Number
    3006948883-2020-00011
    Event Type
    Malfunction
    Date Received
    January 14, 2020
    Date of Event
    December 30, 2019
    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

    H.6 INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9232310. 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. ADDITIONALLY, A SAMPLE WAS RETURNED UPON VISUAL ANALYSIS OF THE RETURNED UNIT IDENTIFIED DAMAGE TO THE EXTENSION TUBING THAT WAS CHARACTERISTIC OF TUBING CLAMP DAMAGE. ANALYSIS OF THE PINCH CLAMP COMPONENT WAS ABLE TO IDENTIFY SIGNIFICANT DAMAGE TO THE CLAMP; A SUBSEQUENT REVIEW OF THE MANUFACTURING PROCESS RULED OUT THE MANUFACTURING PROCESS AS A POSSIBLE CONTRIBUTOR. UNFORTUNATELY BASED ON OUR REVIEW, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT LEAKAGE AT EXT. TUBING DURING USAGE.

    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 YEL 24GAX0.75IN QSYTE-CAPY NOPVC LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT LEAKAGE AT EXT. TUBING DURING USAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52702 PEGASUS YEL 24GAX0.75IN QSYTE-CAPY NOPVC N/A FOZ BD (SUZHOU) 9232310

    Patients

    Seq Age Sex Outcome Treatment
    1 Other