BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y CLOSED IV CATHETER SYSTEMS

    MDR report key: 12200570 · Received July 20, 2021

    Report

    Report Number
    3006948883-2021-00820
    Event Type
    Malfunction
    Date Received
    July 20, 2021
    Date of Event
    June 16, 2021
    Report Date
    July 23, 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

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0231195. 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 SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AFTER INSERTION WITH BD INTIMA-II Y CLOSED IV CATHETER SYSTEMS FLUID LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO DIABETES ON (B)(6) 2021, AND WAS GIVEN INTRAVENOUS INDWELLING NEEDLE FOR INTRAVENOUS INFUSION AT 9:00 A.M. AFTER THE PUNCTURE, FLUID LEAKAGE WAS FOUND IN THE INDWELLING NEEDLE, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED FOR OBSERVATION.

    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 THAT AFTER INSERTION WITH BD INTIMA-II Y CLOSED IV CATHETER SYSTEMS FLUID LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS ADMITTED TO HOSPITAL DUE TO DIABETES ON (B)(6) 2021, AND WAS GIVEN INTRAVENOUS INDWELLING NEEDLE FOR INTRAVENOUS INFUSION AT 9:00 A.M. AFTER THE PUNCTURE, FLUID LEAKAGE WAS FOUND IN THE INDWELLING NEEDLE, AND THE INDWELLING NEEDLE WAS IMMEDIATELY REMOVED FOR OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1094145 BD INTIMA-II Y CLOSED IV CATHETER SYSTEMS INTRAVASCULAR CATHETER FOZ 0231195

    Patients

    Seq Age Sex Outcome Treatment
    1