BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 11084012 · Received December 28, 2020

    Report

    Report Number
    3006948883-2020-01047
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 30, 2020
    Manufacturer
    BD (SUZHOU)
    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 0231222. 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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE NEEDLE TUBE JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "ON (B)(6) 2020, AT 11:37 AM, THE CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED TO PERFORM INTRAVENOUS PUNCTURE SUCCESSFULLY, AND THE DISPOSABLE POUCH INFUSION DEVICE WAS CONNECTED WITH THE NEEDLE FOR TREATMENT. DURING THE FLUID INFUSION, THE NURSE ON DUTY FOUND THAT THE Y TYPE HOSE BASE OF THE CLOSED INTRAVENOUS INDWELLING NEEDLE WAS LEAKING AT THE JUNCTION WITH THE NEEDLE TUBE."

    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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED AT THE NEEDLE TUBE JUNCTION DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "ON (B)(6) 2020, AT 11:37 AM, THE CLOSED INTRAVENOUS INDWELLING NEEDLE WAS USED TO PERFORM INTRAVENOUS PUNCTURE SUCCESSFULLY, AND THE DISPOSABLE POUCH INFUSION DEVICE WAS CONNECTED WITH THE NEEDLE FOR TREATMENT. DURING THE FLUID INFUSION, THE NURSE ON DUTY FOUND THAT THE Y TYPE HOSE BASE OF THE CLOSED INTRAVENOUS INDWELLING NEEDLE WAS LEAKING AT THE JUNCTION WITH THE NEEDLE TUBE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1548831 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0231222

    Patients

    Seq Age Sex Outcome Treatment
    1