BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12534361 · Received September 27, 2021

    Report

    Report Number
    3014704491-2021-00161
    Event Type
    Malfunction
    Date Received
    September 27, 2021
    Date of Event
    August 25, 2021
    Report Date
    October 12, 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

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1020006. 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 H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTING INTRAVENOUS INDWELLING NEEDLE BEFORE OPERATION ON (B)(6) 2021, THE CONNECTION BETWEEN THE CATHETER TUBE AND THE REAR BLUE Y-SHAPED TUBE LEAKED FLUID DURING TUBE SEALING. THE PROBLEM INDWELLING NEEDLE WAS REMOVED, AND THE SAME TYPE OF INDWELLING NEEDLE WAS INSERTED AGAIN. NO ABNORMALITY WAS FOUND IN TUBE SEALING.

    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 THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM EXPERIENCED LEAKAGE AT THE CATHETER AND HUB JUNCTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER INSERTING INTRAVENOUS INDWELLING NEEDLE BEFORE OPERATION ON (B)(6) 2021, THE CONNECTION BETWEEN THE CATHETER TUBE AND THE REAR BLUE Y-SHAPED TUBE LEAKED FLUID DURING TUBE SEALING. THE PROBLEM INDWELLING NEEDLE WAS REMOVED, AND THE SAME TYPE OF INDWELLING NEEDLE WAS INSERTED AGAIN. NO ABNORMALITY WAS FOUND IN TUBE SEALING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1433350 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ 1020006

    Patients

    Seq Age Sex Outcome Treatment
    1