BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10204210 · Received June 26, 2020

    Report

    Report Number
    3006948883-2020-00259
    Event Type
    Malfunction
    Date Received
    June 26, 2020
    Date of Event
    June 8, 2020
    Report Date
    August 14, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A PHYSICAL SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION BUT BD WAS PROVIDED WITH TWO PHOTOS OF THE ISSUE FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED FOR THE REPORTED LOT, 9232327, AND NO QUALITY ISSUES WERE FOUND DURING PRODUCTION. OUR QUALITY ENGINEER REVIEWED THE PROVIDED PHOTOS AND OBSERVED THAT THE TOP DISK WAS PUSHED INTO THE BODY. NO OTHER DAMAGE OR DEFECTS WERE OBSERVED. BASED OFF THE PROVIDED PHOTO THE ENGINEER WAS ABLE TO VERIFY THE REPORTED FAILURE MODE. UNFORTUNATELY, WITHOUT A PHYSICAL SAMPLE AVAILABLE FOR EVALUATION A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXPERIENCED A DEFECTIVE/DAMAGED ADAPTER SEPTUM. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE INTRACARDIAC ICU, WHEN UNPACKING ON 6.8, IT WAS FOUND THAT THE SEPTUM OF THE NEEDLE WAS BROKEN.

    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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXPERIENCED A DEFECTIVE/DAMAGED ADAPTER SEPTUM. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN THE INTRACARDIAC ICU, WHEN UNPACKING ON 6.8, IT WAS FOUND THAT THE SEPTUM OF THE NEEDLE WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668189 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9232327

    Patients

    Seq Age Sex Outcome Treatment
    1 Other