BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9403524 · Received December 3, 2019

    Report

    Report Number
    3006948883-2019-01001
    Event Type
    Malfunction
    Date Received
    December 3, 2019
    Date of Event
    November 13, 2019
    Report Date
    January 6, 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 9023815. 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. 30 SAMPLES WERE RETURNED FOR EVALUATION. ADDITIONALLY TORQUE FORCE TESTING OF THE RETURN UNIT FOUND THAT THE FORCE REQUIRED TO REMOVE THE HEPARIN CAP WAS WITHIN PRODUCT SPECIFICATIONS, AND THAT THE DEVICE WAS OPERATING NORMALLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE CAP WAS LOOSE AND FELL OFF THE NEEDLE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THIS OCCURRED ON 8 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: DURING INTRAVENOUS INFUSION, THE HEPARIN CAP FELL OFF THE NEEDLE, IT CAUSED THE PATIENT'S BLOOD TO FLOW OUT WITHOUT CAUSING POTENTIAL DAMAGE.

    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 THE CAP WAS LOOSE AND FELL OFF THE NEEDLE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THIS OCCURRED ON 8 SEPARATE OCCASIONS DURING USE, HOWEVER, THE DATE/TIME AND OR PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DURING INTRAVENOUS INFUSION, THE HEPARIN CAP FELL OFF THE NEEDLE, IT CAUSED THE PATIENT'S BLOOD TO FLOW OUT WITHOUT CAUSING POTENTIAL DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1201714 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9023814

    Patients

    Seq Age Sex Outcome Treatment
    1 Other