BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16018754 · Received December 20, 2022

    Report

    Report Number
    3014704491-2022-00688
    Event Type
    Malfunction
    Date Received
    December 20, 2022
    Date of Event
    November 3, 2022
    Report Date
    January 20, 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

    A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2110889. 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 NEEDLE LEAKED SALINE WHILE BEING FLUSHED. "THE PATIENT MADE AN APPOINTMENT FOR ENHANCED MRI AT 15:30 ON (B)(6). AFTER THE INDWELLING NEEDLE WAS INSERTED, IT WAS RINSED WITH NORMAL SALINE. THE NORMAL SALINE LEAKED OUT OF THE INDWELLING NEEDLE, WHICH MADE THE INDWELLING NEEDLE UNUSABLE. THE CATHETER WAS REINSERTED."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE LEAKED SALINE WHILE BEING FLUSHED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "THE PATIENT MADE AN APPOINTMENT FOR ENHANCED MRI AT 15:30 ON (B)(6). AFTER THE INDWELLING NEEDLE WAS INSERTED, IT WAS RINSED WITH NORMAL SALINE. THE NORMAL SALINE LEAKED OUT OF THE INDWELLING NEEDLE, WHICH MADE THE INDWELLING NEEDLE UNUSABLE. THE CATHETER WAS REINSERTED.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    476368 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110889

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown