BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 9404729 · Received December 3, 2019

    Report

    Report Number
    3006948883-2019-01006
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 14, 2019
    Report Date
    January 15, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141631. 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 RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. OUR INVESTIGATORS NOTED A SMALL CRACK WAS FOUND DURING LEAKAGE TESTING, THAT WAS LOCATED ON THE ADAPTER. THE RETURNED PRODUCT'S SWAGE DIMENSIONS WERE MEASURED BY OUR TEAM AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW. H3 OTHER TEXT: SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM NEEDLE HUB WAS BROKEN DURING USE AND CAUSED BLOOD LEAKAGE AFTER THE PENETRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "IT'S NOTICED THAT NEEDLE HUB BROKEN AND LEAD TO BLOOD LEAKAGE AT THE NEEDLE HUB AFTER COMPLETED PENETRATION."

    Additional Manufacturer Narrative · 1

    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 THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM NEEDLE HUB WAS BROKEN DURING USE AND CAUSED BLOOD LEAKAGE AFTER THE PENETRATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "IT'S NOTICED THAT NEEDLE HUB BROKEN AND LEAD TO BLOOD LEAKAGE AT THE NEEDLE HUB AFTER COMPLETED PENETRATION".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1202071 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9141631

    Patients

    Seq Age Sex Outcome Treatment
    1 Other