BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PA-FS# SAFESTEP

    MDR report key: 21763274 · Received April 3, 2025

    Report

    Report Number
    3006260740-2025-01967
    Event Type
    Malfunction
    Date Received
    April 3, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 22, 2025
    Manufacturer
    C.R. BARD, INC. (BASD) -3006260740
    Product Code
    FPA
    UDI-DI
    00801741066177
    PMA / PMN Number
    K153440
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. EACH EVENT REPORTED TO BD IS EVALUATED AND INVESTIGATED IN ACCORDANCE WITH OUR COMPLAINT INVESTIGATION PROCEDURES. THE INVESTIGATION PROCESS INCLUDES, BUT IS NOT LIMITED TO, EVALUATION OF THE EVENT DETAILS PROVIDED BY THE COMPLAINT FACILITY, A REVIEW OF COMPLAINT HISTORY, MANUFACTURING RECORDS AND RISK DOCUMENT WHERE APPLICABLE, AND AN EVALUATION OF THE SUBJECT DEVICE WHEN AVAILABLE TO IDENTIFY POTENTIAL CONTRIBUTING FACTORS. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    H11: SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. THE COMPLAINT OF A LEAK COULD NOT BE CONFIRMED. THE PRODUCT RETURNED FOR EVALUATION WAS ONE 22G SAFESTEP INFUSION SET W/ Y-SITE. A GROSS VISUAL INSPECTION OF THE RETURNED UNIT FOUND NO DAMAGE OR DEFECTS TO THE COMPONENTS. THE UNIT WAS LEAK TESTED BY FLUSHING BOTH THE PROXIMAL LUER AND Y-SITE WITH WATER USING A LUER LOCK SYRINGE. DURING TESTING NO LEAKS WERE OBSERVED. ADDITIONALLY, ASPIRATION WAS ATTEMPTED AND THE UNIT WAS FOUND TO FUNCTION AS INTENDED. BASED ON THE AVAILABLE EVIDENCE, THE REPORTED DEFECT COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CHECKING FOR BACKFLOW, AIR CAME OUT ALONG WITH THE BLOOD. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1459747 PA-FS# SAFESTEP PORT ACCESS NEEDLE FPA C.R. BARD, INC. (BASD) -3006260740 N/A UNK 00801741066177

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other