BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

    MDR report key: 10891195 · Received November 24, 2020

    Report

    Report Number
    3006948883-2020-00820
    Event Type
    Malfunction
    Date Received
    November 24, 2020
    Date of Event
    October 25, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050885. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT 10:00 ON (B)(6) 2020, THE CHILD WAS GIVEN A HAND INFUSION OF INDWERED NEEDLE. WHEN THE FAMILY MEMBER FOUND FLUID LEAKAGE AT THE JUNCTION AT 11:00, THEY IMMEDIATELY CALLED THE NURSE. NO FLUID LEAKAGE OCCURRED AFTER REPLACING THE INDWELLING NEEDLE AT 11:10 ADR# (B)(4).

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "AT 10:00 A.M., ON (B)(6) 2020, THE CHILD WAS GIVEN A HAND INFUSION OF INDWERED NEEDLE. WHEN THE FAMILY MEMBER FOUND FLUID LEAKAGE AT THE JUNCTION AT 11:00, THEY IMMEDIATELY CALLED THE NURSE. NO FLUID LEAKAGE OCCURRED AFTER REPLACING THE INDWELLING NEEDLE AT 11:10 ADR# (B)(4)."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1361424 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050885

    Patients

    Seq Age Sex Outcome Treatment
    1