BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y18GAX1.16IN PRN/EC SLM

    MDR report key: 10989144 · Received December 10, 2020

    Report

    Report Number
    3006948883-2020-00939
    Event Type
    Malfunction
    Date Received
    December 10, 2020
    Date of Event
    November 10, 2020
    Report Date
    December 22, 2020
    Manufacturer
    BD (SUZHOU)
    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 0140311. 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 A INTIMA-II Y18GAX1.16IN PRN/EC SLM LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "AT 16:20 ON (B)(6), NURSE (B)(6) USED INDWELLING NEEDLE TO PUNCTURE IN ORDER TO PROTECT BLOOD VESSELS. AFTER THE PUNCTURE WAS SUCCESSFULLY FIXED, IT WAS FOUND THAT THERE WAS LEAKAGE BETWEEN THE Y TUBE OF INDWELLING NEEDLE AND THE HOSE. (B)(6) IMMEDIATELY PULLED OUT THE INDWELLER NEEDLE, GIVE THE PATIENT PSYCHOLOGICAL COMFORT, REPLACE THE INTACT INDWELLER NEEDLE PUNCTURE, THE PATIENT AND HIS FAMILY SHOWED UNDERSTANDING."

    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 A INTIMA-II Y18GAX1.16IN PRN/EC SLM LEAKED DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "AT 16:20 ON (B)(6), NURSE (B)(6) USED INDWELLING NEEDLE TO PUNCTURE IN ORDER TO PROTECT BLOOD VESSELS. AFTER THE PUNCTURE WAS SUCCESSFULLY FIXED, IT WAS FOUND THAT THERE WAS LEAKAGE BETWEEN THE Y TUBE OF INDWELLING NEEDLE AND THE HOSE. (B)(6) IMMEDIATELY PULLED OUT THE INDWELLER NEEDLE, GIVE THE PATIENT PSYCHOLOGICAL COMFORT, REPLACE THE INTACT INDWELLER NEEDLE PUNCTURE, THE PATIENT AND HIS FAMILY SHOWED UNDERSTANDING. "

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1446221 INTIMA-II Y18GAX1.16IN PRN/EC SLM INTRAVASCULAR ADMINISTRATION SET FOZ BD (SUZHOU) 0140311

    Patients

    Seq Age Sex Outcome Treatment
    1