BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 10300036 · Received July 20, 2020

    Report

    Report Number
    3006948883-2020-00298
    Event Type
    Malfunction
    Date Received
    July 20, 2020
    Date of Event
    May 13, 2020
    Report Date
    August 3, 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 SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9232318 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. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM EXPERIENCED A UNIT PACKAGE/SEAL WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BENT AND THE PACKAGE WAS DAMAGED WHEN PREPARING TO GIVE THE PATIENT AN INFUSION EXAMINATION INSTRUMENT.

    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 UNIT PACKAGE/SEAL WHERE STERILITY WAS COMPROMISED. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE NEEDLE WAS BENT AND THE PACKAGE WAS DAMAGED WHEN PREPARING TO GIVE THE PATIENT AN INFUSION EXAMINATION INSTRUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758031 BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9232318

    Patients

    Seq Age Sex Outcome Treatment
    1 Other