BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 8782062 · Received July 11, 2019

    Report

    Report Number
    3006948883-2019-00540
    Event Type
    Malfunction
    Date Received
    July 11, 2019
    Date of Event
    June 21, 2019
    Report Date
    September 5, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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 8141383. 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. ADDITIONALLY DURING THEIR REVIEW OF THE RETURNED DEVICE, OUR ENGINEERS IDENTIFIED DAMAGE TO THE ADAPTER THAT RESULTED IN CONTACT WITH THE ADAPTER PADDLE. A REVIEW OF THE MANUFACTURING LINE WAS CONDUCTED, HOWEVER OUR ENGINEERS WERE UNABLE TO IDENTIFY A POSSIBLE SOURCE FOR THE OBSERVED DAMAGE AT THIS TIME. H3 OTHER TEXT: SEE SECTION H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT'S NOTICED THAT NEEDLE CORE STUCK AND UNABLE TO RETRACT OUT DURING RETRACTION PROCESS. DEFECTED PRODUCT IS USED AS CLINICAL SAMPLE, DIDN¿T BE USED." 50 OCCURRENCES WERE REPORTED, THE DATE/TIME OF EACH EVENT WAS NOT GIVEN.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 NEEDLE RETRACTION FAILURE OCCURRED DURING USE WITH A BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT'S NOTICED THAT NEEDLE CORE STUCK AND UNABLE TO RETRACT OUT DURING RETRACTION PROCESS. DEFECTED PRODUCT IS USED AS CLINICAL SAMPLE, DIDN¿T BE USED." 50 OCCURRENCES WERE REPORTED, THE DATE/TIME OF EACH EVENT WAS NOT GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573045 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 8141383 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 Other