BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INSYTE-A¿ ARTERIAL CATHETER

    MDR report key: 16109150 · Received January 5, 2023

    Report

    Report Number
    9610847-2022-00511
    Event Type
    Malfunction
    Date Received
    January 5, 2023
    Date of Event
    December 7, 2022
    Report Date
    January 20, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL? YES. D10: RETURNED TO MANUFACTURER ON: 11-JAN-2023. H6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2101874. 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. ADDITIONALLY, TWO SAMPLES WERE RETURNED TO AID IN OUR INVESTIGATION. DURING VISUAL ANALYSIS, OUR ENGINEERS WERE ABLE TO IDENTIFY A SMALL BLACK SPEC ON THE PAPER BACKING OF THE PACKAGING. UNFORTUNATELY, DUE TO THE SIZE OF THE MATERIAL, OUR ENGINEERS WERE NOT ABLE TO SUCCESSFULLY COLLECT THE SAMPLE FOR COMPOSITIONAL TESTING. THIS EVENT HAS BEEN CONFIRMED. THE MOST LIKELY ROOT CAUSE FOR GENERAL FOREIGN MATTER IS DIFFICULT TO IDENTIFY, AS IT CAN ORIGINATE FROM PACKAGING PERSONNEL OR RAW MATERIALS BROUGHT INTO THE MANUFACTURING ROOM.

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE-A¿ ARTERIAL CATHETER FOREIGN MATTER WAS FOUND BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT FOREIGN MATTER IN THE PACKAGE OF INSYTE-A. ACCORDING TO THE CUSTOMER¿S REPORT, FM ADHERING TO THE CATHETER SITE WAS FOUND BEFORE USE. THE SALES REP'S COMMENTS ARE AS FOLLOWS: THERE ARE CLOTH-LIKE FIBERS (WHITE) INSIDE THE CAP. PLEASE BE CAREFUL WHEN REMOVING THE CAP AS IT IS HARD TO SEE IT WITH HUMAN EYES.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INSYTE-A¿ ARTERIAL CATHETER FOREIGN MATTER WAS FOUND BEFORE USE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT FOREIGN MATTER IN THE PACKAGE OF INSYTE-A. ACCORDING TO THE CUSTOMER¿S REPORT, FM ADHERING TO THE CATHETER SITE WAS FOUND BEFORE USE. THE SALES REP.'S COMMENTS ARE AS FOLLOWS: THERE ARE CLOTH-LIKE FIBERS (WHITE) INSIDE THE CAP. PLEASE BE CAREFUL WHEN REMOVING THE CAP AS IT IS HARD TO SEE IT WITH HUMAN EYES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192423 BD INSYTE-A¿ ARTERIAL CATHETER INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2101874

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown