BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 15194623 · Received August 9, 2022

    Report

    Report Number
    3014704491-2022-00337
    Event Type
    Malfunction
    Date Received
    August 9, 2022
    Date of Event
    July 15, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2080990. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED SAMPLES COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. UNFORTUNATELY 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 PACKAGE UNITS OF 50 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS WERE DAMAGED AND SQUEEZED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER THE DISTRIBUTOR DELIVERED THE GOODS AND THE HOSPITAL EQUIPMENT DEPARTMENT RECEIVED THE GOODS, IT WAS FOUND THAT THE OUTER PACKAGING OF THE BOX WAS INTACT. AFTER OPENING THE SMALL BOX, IT WAS FOUND THAT THE OUTER PACKAGING OF THE PRODUCT WAS SQUEEZED AND DAMAGED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PACKAGE UNITS OF 50 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEMS WERE DAMAGED AND SQUEEZED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AFTER THE DISTRIBUTOR DELIVERED THE GOODS AND THE HOSPITAL EQUIPMENT DEPARTMENT RECEIVED THE GOODS, IT WAS FOUND THAT THE OUTER PACKAGING OF THE BOX WAS INTACT. AFTER OPENING THE SMALL BOX, IT WAS FOUND THAT THE OUTER PACKAGING OF THE PRODUCT WAS SQUEEZED AND DAMAGED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287854 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2080990

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown