BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16906558 · Received May 10, 2023

    Report

    Report Number
    3014704491-2023-00178
    Event Type
    Malfunction
    Date Received
    May 10, 2023
    Date of Event
    March 26, 2023
    Report Date
    May 12, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2172312. 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT AROUND 9:00 AM ON (B)(6) 2023, THE NURSE WAS PERFORMING INTRAVENOUS TREATMENT FOR THE PATIENT. THE PATIENT REQUESTED TO INDWELL A SOFT NEEDLE. THE NURSE CONNECTED THE INDWELLING NEEDLE TO THE INFUSION SET, DRAINED THE FLUID, AND PUNCTURED WITH THE INDWELLING NEEDLE. AFTER SEEING THE RETURN OF BLOOD, THE NEEDLE WAS WITHDRAWN IN PARALLEL. OPEN THE INFUSION CLAMP AND FIND THAT THE NEEDLE CORE OF THE INDWELLING NEEDLE LEAKS BLOOD AND FLUID AT A DISTANCE OF 0.5 CM FROM THE NEEDLE BARREL. CLOSE THE INFUSION CLAMP IMMEDIATELY, PULL OUT THE NEEDLE, AND REPLACE IT WITH A NEW INDWELLING NEEDLE FOR PUNCTURE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED BLOOD DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "AT AROUND (B)(6) 2023, THE NURSE WAS PERFORMING INTRAVENOUS TREATMENT FOR THE PATIENT. THE PATIENT REQUESTED TO INDWELL A SOFT NEEDLE. THE NURSE CONNECTED THE INDWELLING NEEDLE TO THE INFUSION SET, DRAINED THE FLUID, AND PUNCTURED WITH THE INDWELLING NEEDLE. AFTER SEEING THE RETURN OF BLOOD, THE NEEDLE WAS WITHDRAWN IN PARALLEL. OPEN THE INFUSION CLAMP AND FIND THAT THE NEEDLE CORE OF THE INDWELLING NEEDLE LEAKS BLOOD AND FLUID AT A DISTANCE OF 0.5 CM FROM THE NEEDLE BARREL. CLOSE THE INFUSION CLAMP IMMEDIATELY, PULL OUT THE NEEDLE, AND REPLACE IT WITH A NEW INDWELLING NEEDLE FOR PUNCTURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199347 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2172312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown