BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 17687123 · Received September 5, 2023

    Report

    Report Number
    3014704491-2023-00515
    Event Type
    Malfunction
    Date Received
    September 5, 2023
    Date of Event
    August 18, 2023
    Report Date
    October 20, 2023
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2228390. 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 EFFECTED SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. E.1. INITIAL REPORTER PHONE #: (B)(6). H3. 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 · 0

    IT WAS REPORTED THAT 25 OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WERE LEAKING. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO THE SALES REPORT, THE HEAD NURSE HAS ACCUMULATED 25 PROBLEMATIC PRODUCTS SINCE JULY 18, AND FOUND THAT THE ISOLATION PLUG OOZES BLOOD DURING THE USE OF THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 25 OF THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM WERE LEAKING. THE FOLLOWING WAS TRANSLATED FROM CHINESE TO ENGLISH: ACCORDING TO THE SALES REPORT, THE HEAD NURSE HAS ACCUMULATED 25 PROBLEMATIC PRODUCTS SINCE (B)(6), AND FOUND THAT THE ISOLATION PLUG OOZES BLOOD DURING THE USE OF THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1055995 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2228390

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown