BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM

    MDR report key: 15034150 · Received July 15, 2022

    Report

    Report Number
    3014704491-2022-00282
    Event Type
    Malfunction
    Date Received
    July 15, 2022
    Date of Event
    June 17, 2022
    Report Date
    July 31, 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

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2010599. 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. CHECKED THE RETAINED SAMPLE OF COMPLAINT LOT,NO ABNORMALITY WAS OBSERVED ON THE RETAINED SAMPLE. OUR ENGINEERS NOTED THAT THE SHRINK WRAP ON THE END CAP WAS ASKEW AND DID NOT FORM A PROPER SEAL WHICH WOULD LEAD TO A LEAK. THE ISSUE HAS BEEN CONFIRMED. AFTER REVIEWING THE MANUFACTURING PROCESS OUR ENGINEERS HAVE DETERMINED THAT THE ROOT CAUSE FOR THIS ISSUE IS RELATED TO NATURAL VARIANCE OF THE SHRINK-WRAPPING PROCESS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED AT THE DIAPHRAGM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PRN WAS NOT SEALED PROPERLY AFTER THE PATIENT WAS PUNCTURED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM LEAKED AT THE DIAPHRAGM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PRN WAS NOT SEALED PROPERLY AFTER THE PATIENT WAS PUNCTURED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2873564 BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2010599

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown