BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PEGASUS YEL 24GA X 0.75IN PRN NON-PVC

    MDR report key: 9547625 · Received January 3, 2020

    Report

    Report Number
    3006948883-2019-01169
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 23, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR EVALUATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9021613. 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 FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY EVALUATION OF THE RETURNED UNITS WAS NOT ABLE TO IDENTIFY THE REPORTED FAILURE MODE. THE UNITS WERE FOUND TO BE WITHIN THE PARAMETERS ESTABLISHED BY PRODUCT SPECIFICATIONS, FURTHER, PUNCTURING TESTING OF THE SUBMITTED DEVICE DETERMINE THAT THE UNIT WAS OPERATING AS INTENDED. BASED ON OUR FINDINGS, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE ASSOCIATED WITH THE MANUFACTURING PROCESS AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEGASUS YEL 24GA X 0.75IN PRN NON-PVC EXPERIENCED SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL) DIFFICULT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USAGE, SEVERAL EAS PEGASUS WAS NOTICED WITH CATHTER KINKED AND RESULT IN PENETRATIN FAILURE SEVERAL EAS PEGASUS WAS NOTICED WITH NEEDLE DISENGAGEMENT FAILURE/DIFFICULT.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEGASUS YEL 24GA X 0.75IN PRN NON-PVC EXPERIENCED SAFETY MECHANISM/NEEDLE DISENGAGEMENT (REMOVAL) DIFFICULT. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING USAGE, SEVERAL EAS PEGASUS WAS NOTICED WITH CATHETER KINKED AND RESULT IN PENETRATIN FAILURE. SEVERAL EAS PEGASUS WAS NOTICED WITH NEEDLE DISENGAGEMENT FAILURE/DIFFICULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12391 PEGASUS YEL 24GA X 0.75IN PRN NON-PVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9021613

    Patients

    Seq Age Sex Outcome Treatment
    1 Other