BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 10089203 · Received May 26, 2020

    Report

    Report Number
    3006948883-2020-00194
    Event Type
    Malfunction
    Date Received
    May 26, 2020
    Date of Event
    April 8, 2020
    Report Date
    June 1, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FPA
    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

    H.6. INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141727. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THEY DID NOT DISPLAY THE FAILURE MODE CLEARLY ENOUGH TO IDENTIFY THE ROOT CAUSE. A SUBSEQUENT REVIEW OF THE FACTORY PROCESS WAS LAUNCHED IN RESPONSE TO THIS EVENT; THE REVIEW CONCLUDED AFTER NO OPPORTUNITIES WERE IDENTIFIED THAT COULD HAVE MANUFACTURED THE OBSERVED DAMAGE DURING THE MANUFACTURING PROCESS. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE DOCTOR'S INSTRUCTIONS FOR INTRAVENOUS INFUSION TO THE PATIENT, THE BD 24G INDWELLING NEEDLE HAD USED FOR 3 DAYS, THE EXTENSION TUBE WAS BROKEN OUTSIDE THE CLAMP, AND IT WAS IMMEDIATELY EXTUBATED.

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING WAS DAMAGED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOLLOWING THE DOCTOR'S INSTRUCTIONS FOR INTRAVENOUS INFUSION TO THE PATIENT, THE BD 24G INDWELLING NEEDLE HAD USED FOR 3 DAYS, THE EXTENSION TUBE WAS BROKEN OUTSIDE THE CLAMP, AND IT WAS IMMEDIATELY EXTUBATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553725 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM CATHETER FPA BD (SUZHOU) 9141727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other