BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 9546440 · Received January 3, 2020

    Report

    Report Number
    8041187-2019-01065
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    December 19, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BECTON DICKINSON MEDICAL (SINGAPORE)
    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 SUMMARY BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR EVALUATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9081867. 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, DURING THE VISUAL EVALUATION OF THE RETURNED DEVICE, BD ENGINEERS IDENTIFIED CHARACTERISTICS, IN THE BROKEN EDGE OF THE EXTENSION TUBING, THAT ARE CHARACTERISTIC OF CLAMP DAMAGE. THE CORRESPONDING SLIDE CLAMP WAS INSPECTED AND MEASURED, AND FOUND TO BE WITH THE DIMENSIONAL LIMITATIONS SET BY PRODUCT SPECIFICATIONS. TO ADDRESS THIS ISSUE HAS INITIATED A PROJECT TO CHANGE THE SLIDE CLAMP TO A LESS ABRASIVE PINCH CLAMP. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM'S EXTENSION TUBING WAS FOUND DAMAGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "DURING USAGE,IT'S NOTICED THAT EXT. TUBING DAMAGED".

    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'S EXTENSION TUBING WAS FOUND DAMAGED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "DURING USAGE, IT'S NOTICED THAT EXT. TUBING DAMAGED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12344 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL (SINGAPORE) 9081867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other