BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN

    MDR report key: 10557287 · Received September 18, 2020

    Report

    Report Number
    9610847-2020-00289
    Event Type
    Malfunction
    Date Received
    September 18, 2020
    Date of Event
    August 28, 2020
    Report Date
    November 20, 2020
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903835943
    PMA / PMN Number
    K173354
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR PROVIDED LOT NUMBER 0052947 AND THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS REPORTED INCIDENT. TO AID IN THE INVESTIGATION OF THIS ISSUE, THIRTY REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM ALONG WITH PICTURE SAMPLES. THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLES, THE YELLOW CONDITION WAS OBSERVED ON ALL OF THE SAMPLES RECEIVED. THE YELLOW CONDITION IS CONSIDERED A NORMAL PART OF THE MANUFACTURING PROCESS AS IT RESULTS FROM THE LASER HOLE DRILLING PROCESS. THE YELLOW COLOR OBSERVED IS NOT FOREIGN MATTER AND IS NOT CONSIDERED A DEFECT WITH THE PRODUCT. OUR QUALITY TEAM WILL CLOSELY MONITOR THE PRODUCTION PROCESS FOR ISSUES RELATED TO THE LASER HOLE DRILLING PROCESS AND ANY EMERGING TRENDS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 40 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383594 BATCH NO.: 0052947. THE USER FACILITY OPENED MATERIAL 383594 AND SAW WHAT THEY DESCRIBE AS " YELLOW DEBRIS NEAR THE GREEN BUTTERFLY WHERE THE TUBE IS". NURSE SAW THIS WHEN SHE OPENED THE PACKAGING. THEY HAVE PULLED THE LOT AND ARE SEQUESTERING IT AS A PRECAUTION.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 40 BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN EXPERIENCED FOREIGN MATTER CONTAMINATION WHICH WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 383594 BATCH NO.: 0052947 THE USER FACILITY OPENED MATERIAL 383594 AND SAW WHAT THEY DESCRIBE AS " YELLOW DEBRIS NEAR THE GREEN BUTTERFLY WHERE THE TUBE IS". NURSE SAW THIS WHEN SHE OPENED THE PACKAGING. THEY HAVE PULLED THE LOT AND ARE SEQUESTERING IT AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1021972 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM 18 GA 1.25 IN INTERVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383594 0052947 30382903835943

    Patients

    Seq Age Sex Outcome Treatment
    1 Other