BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 20GAX1.16IN PRN/EC SLM

    MDR report key: 9547048 · Received January 3, 2020

    Report

    Report Number
    3006948883-2019-01168
    Event Type
    Malfunction
    Date Received
    January 3, 2020
    Date of Event
    July 28, 2019
    Report Date
    January 27, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    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 9023788. 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. UNFORTUNATELY, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 20GAX1.16IN PRN/EC SLM EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "EPISODIC WHEEZING FOR 2 DAYS AND RE-ACCESSED FOR 2+ HOURS". THE PATIENT NEEDED TO BE GIVEN INFUSION FOR TREATMENT THIS MORNING. AFTER OPENING THE PACKAGE OF INDWELLING NEEDLE, IT WAS FOUND THAT THE NEEDLE WAS DAMAGED. THE INDWELLING NEEDLE WAS NOT USED.

    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 THE INTIMA-II Y 20GAX1.16IN PRN/EC SLM EXPERIENCED PRODUCT DAMAGE/DEFORMATION WITH THE DEVICE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO "EPISODIC WHEEZING FOR 2 DAYS AND RE-ACCESSED FOR 2+ HOURS". THE PATIENT NEEDED TO BE GIVEN INFUSION FOR TREATMENT THIS MORNING. AFTER OPENING THE PACKAGE OF INDWELLING NEEDLE, IT WAS FOUND THAT THE NEEDLE WAS DAMAGED. THE INDWELLING NEEDLE WAS NOT USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12190 INTIMA-II Y 20GAX1.16IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9023788

    Patients

    Seq Age Sex Outcome Treatment
    1 Other