BEUDAMED
    FDA Adverse Event Injury Summary report: N

    22G X 1.00IN (0.9 X 25 MM) W/ Y INTIMA II

    MDR report key: 8776893 · Received July 10, 2019

    Report

    Report Number
    3006948883-2019-00530
    Event Type
    Injury
    Date Received
    July 10, 2019
    Date of Event
    January 8, 2019
    Report Date
    August 1, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    K143610
    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 6294176. 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, A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING, BUT THIS LOT WAS TREATED AND RECEIVED A CERTIFICATE OF CONFORMANCE FOR STERILITY. UNFORTUNATELY, WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE 22G X 1.00IN (0.9 X 25 MM) W/ Y INTIMA II CAUSED AN ALLERGIC REACTION TO THE PATIENT, REQUIRING MEDICAL INTERVENTION. INCIDENT OCCURRED DURING USE OF THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL HOURS AFTER USAGE OF THE CATHETER, SKIN REACTIONS INCLUDING REDNESS, ITCHING NOTICED ON THE PATIENT MEDICAL INTERVENTION HAS BEEN TAKEN ON THE PATIENT REACTIONS HAS BEEN TURNED DOWN

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 22G X 1.00IN (0.9 X 25 MM) W/ Y INTIMA II CAUSED AN ALLERGIC REACTION TO THE PATIENT, REQUIRING MEDICAL INTERVENTION. INCIDENT OCCURRED DURING USE OF THE DEVICE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SEVERAL HOURS AFTER USAGE OF THE CATHETER, SKIN REACTIONS INCLUDING REDNESS, ITCHING NOTICED ON THE PATIENT. MEDICAL INTERVENTION HAS BEEN TAKEN ON THE PATIENT. REACTIONS HAS BEEN TURNED DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571214 22G X 1.00IN (0.9 X 25 MM) W/ Y INTIMA II INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 6294176

    Patients

    Seq Age Sex Outcome Treatment
    1 Other