BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA II¿ IV CATHETER PRN ADAPTER

    MDR report key: 12185922 · Received July 16, 2021

    Report

    Report Number
    3006948883-2021-00803
    Event Type
    Malfunction
    Date Received
    July 16, 2021
    Date of Event
    June 17, 2021
    Report Date
    July 25, 2021
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVALUATION?: YES. D.10. RETURNED TO MANUFACTURER ON: 7/5/2021 H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020006. 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. A PHOTOGRAPH OF THE AFFECTED DEVICE AND 12 PHYSICAL SAMPLES WERE RETURNED. BASED ON VISUAL ANALYSIS OF THE SUBMITTED DEVICES OUR ENGINEERS WERE ABLE TO DETERMINE THAT THE VARIANCE IN COLOR IS THE RESULT OF EXPECTED VARIATION IN THE COLORATION OF THE RAW MATERIAL. CLOSER INSPECTION OF THE SURFACE OF EACH DEVICE, FOUND THE RAW MATERIAL TO BE FREE OF ANY SIGNS OF AGING, AND FUNCTIONAL TESTING CONFIRMED THAT ALL TESTED DEVICES OPERATED AS INTENDED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER PRN ADAPTERS THE END CAPS WERE DISCOLORED. THIS EVENT OCCURRED 13 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "BEFORE OPENING THE PACKAGES, THE COLOR OF THE PRN BECAME DARK YELLOW.".

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED WHEN USING THE BD INTIMA II¿ IV CATHETER PRN ADAPTERS THE END CAPS WERE DISCOLORED. THIS EVENT OCCURRED 13 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER AND TRANSLATED TO ENGLISH. THE CUSTOMER STATED: "BEFORE OPENING THE PACKAGES, THE COLOR OF THE PRN BECAME DARK YELLOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1082516 BD INTIMA II¿ IV CATHETER PRN ADAPTER INTRAVASCULAR CATHETER FOZ 1020006

    Patients

    Seq Age Sex Outcome Treatment
    1