BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9505576 · Received December 20, 2019

    Report

    Report Number
    3006948883-2019-01114
    Event Type
    Malfunction
    Date Received
    December 20, 2019
    Date of Event
    October 6, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171139. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE. H3 OTHER TEXT : SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE THE CATHETER WAS BENDING WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO HOSPITAL FOR "CESAREAN SECTION". BEFORE THE OPERATION, THE PATIENT WAS GIVEN INTRAVENOUS ACCESS AND INTRAVENOUS INFUSION OF INDWELLING NEEDLE. ON (B)(6) 2019, THE INDWELLING NEEDLE WAS FOUND TO BE BENDING. DURING THE WARD ROUNDS, THE NURSE TOOK OUT THE INDWELLING NEEDLE AND NO ADVERSE EVENTS OCCURRED.

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER PHONE #: UNKNOWN. 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 DURING USE THE CATHETER WAS BENDING WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ON (B)(6) 2019, THE PATIENT WAS ADMITTED TO HOSPITAL FOR "CESAREAN SECTION". BEFORE THE OPERATION, THE PATIENT WAS GIVEN INTRAVENOUS ACCESS AND INTRAVENOUS INFUSION OF INDWELLING NEEDLE. ON (B)(6) 2019, THE INDWELLING NEEDLE WAS FOUND TO BE BENDING. DURING THE WARD ROUNDS, THE NURSE TOOK OUT THE INDWELLING NEEDLE AND NO ADVERSE EVENTS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1302541 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8171139

    Patients

    Seq Age Sex Outcome Treatment
    1 Other