BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8210541 · Received January 2, 2019

    Report

    Report Number
    3006948883-2018-00337
    Event Type
    Malfunction
    Date Received
    January 2, 2019
    Date of Event
    December 16, 2018
    Report Date
    January 11, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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 SAMPLE WAS RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8141394 OUR RECORDS DETERMINED THAT THIS IS THE ONLY INSTANCE OF A OCCLUDED DEVICE 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. INVESTIGATION CONCLUSION: OUR INVESTIGATORS NOTED A SMALL CRACK WAS FOUND DURING LEAKAGE TESTING THAT WAS LOCATED ON THE ADAPTER. THE RETURNED PRODUCT'S SWAGE DIMENSIONS WERE MEASURED BY OUR TEAM AND FOUND TO BE WITHIN PRODUCT SPECIFICATIONS. HOWEVER ACCORDING TO PREVIOUS INVESTIGATIONS, DEPENDING ON PRESSURE VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO BECOME MISALIGNED ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE; A REVIEW OF OUR LINE DETERMINED THAT THE MACHINE IS IN THE PROPER ORIENTATION AND OPERATING NORMALLY. ROOT CAUSE DESCRIPTION: BD IS CURRENTLY CONDUCTING A LONG TERM STUDY TO DETERMINE THE ROOT CAUSE FOR THIS EVENT; PRELIMINARY RESULTS SUGGEST THAT A MISALIGNMENT IN THE MANUFACTURING MACHINERY MAY BE RESPONSIBLE FOR THIS EVENT. RATIONALE: BD WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS LEAKED 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 A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM WAS LEAKED DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3547 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141394 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Other