BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 9172957 · Received October 9, 2019

    Report

    Report Number
    3006948883-2019-00849
    Event Type
    Malfunction
    Date Received
    October 9, 2019
    Date of Event
    September 19, 2019
    Report Date
    October 29, 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
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141586. 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. DURING THE EVALUATION OF THE SUBMITTED DEVICE OUR ENGINEERS WERE UNABLE TO IDENTIFY AN FOREIGN MATERIAL. UNFORTUNATELY WITHOUT THE ABILITY TO OBSERVE THE REPORTED FAILURE MODE, THE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE DETERMINED AT THE CONCLUSION OF OUR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT FOREIGN MATTER WAS FOUND BEFORE USE WITH A INTIMA-II 20GAX1.16IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CUSTOMER FOUND THAT THE NEEDLE TIP OF THE PRODUCT WAS BLACK WITH BLACK SPOTS ON SEPTEMBER 19." 100 OCCURRENCES WERE REPORTED.

    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 FOREIGN MATTER WAS FOUND BEFORE USE WITH A INTIMA-II 20GAX1.16IN PRN SLM NPVC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE CUSTOMER FOUND THAT THE NEEDLE TIP OF THE PRODUCT WAS BLACK WITH BLACK SPOTS ON (B)(6)." 100 OCCURRENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    964732 INTIMA-II 20GAX1.16IN PRN SLM NPVC INTERVASCULAR CATHETER FOZ BD (SUZHOU) 9141586

    Patients

    Seq Age Sex Outcome Treatment
    1 Other