BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8265448 · Received January 21, 2019

    Report

    Report Number
    3006948883-2019-00002
    Event Type
    Malfunction
    Date Received
    January 21, 2019
    Date of Event
    January 5, 2019
    Report Date
    January 24, 2019
    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
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233343. OUR RECORDS SHOW THAT THIS IS THE FIRST INSTANCE OF A DAMAGED ADAPTER OCCURRING IN THIS BATCH OF INTIMA II. 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. INVESTIGATION CONCLUSION: WITH THE PHOTO PROVIDED, OUR ENGINEERS WERE ABLE TO DETERMINE THAT THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE. CAPA # 642738 HAS BEEN INITIATED TO DEAL WITH THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT TWO OF BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS WERE LEAKED AT TUBING AND Y-CONNECTION DURING USE.

    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 TWO OF BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS WERE LEAKED AT TUBING AND Y-CONNECTION DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58570 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8233343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other