BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DIFFUSICS 22G X 1.00 IN

    MDR report key: 19448211 · Received June 3, 2024

    Report

    Report Number
    9610847-2024-00154
    Event Type
    Malfunction
    Date Received
    June 3, 2024
    Date of Event
    May 5, 2024
    Report Date
    October 7, 2024
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903836925
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 383692 AND LOT NUMBER 3192383. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 2 PHOTOS AND 1 PHYSICAL SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF CATHETER BROKE/SEPARATED AFTER PLACEMENT WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED FLUORESCENCE OF THE ADHESIVE AT THE TIP OF THE TUBE. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS LACK OF ADHESIVE, LACK OF CURING, INCORRECT EXECUTION OF INSPECTION DURING MANUFACTURING. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEXIVA DIFFUSICS 22G X 1.00 IN CATHETER BROKECANNULA BROKE DURING THE POWER INJECTION.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1826603 BD NEXIVA DIFFUSICS 22G X 1.00 IN INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 3192383 00382903836925

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown