BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC

    MDR report key: 9124423 · Received September 26, 2019

    Report

    Report Number
    3006948883-2019-00810
    Event Type
    Malfunction
    Date Received
    September 26, 2019
    Date of Event
    August 26, 2019
    Report Date
    October 8, 2019
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    UNKNOWN
    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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8171129. 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. NO ABNORMALITIES COULD BE IDENTIFIED IN THE RETENTION SAMPLES AVAILABLE FOR THIS LOT NUMBER DESPITE ATTEMPTS TO IDENTIFY THE CAUSE USING LEAKAGE TESTING AND MICROSCOPIC EVALUATION OF THE DEVICE. 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 DURING USE OF THE INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC THERE WAS AN ISSUE WITH LEAKAGE ON THE SECOND DAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT UNDERWENT PAINLESS UTERINE CURETTAGE ON (B)(6) 2019 BECAUSE OF EARLY PREGNANCY AND ABORTION. THE INTRAVENOUS CHANNEL WAS ESTABLISHED BY INDWELLING NEEDLE BEFORE OPERATION, AND THE CATHETER WAS SEALED BY ROUTINE INDWELLING NEEDLE AFTER THE COMPLETION OF FLUID INFUSION ON THAT DAY. DURING INTRAVENOUS INFUSION ON AUGUST 26, LEAKAGE OF THE TAIL OF THE INDWELLING NEEDLE WAS FOUND AND COULD NOT BE CONTINUED. RE-PUNCTURE WITH ONE-TIME INFUSION AFTER REMOVAL OF INDWELLING NEEDLE.

    Additional Manufacturer Narrative · 1

    A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION AND/OR DEVICE HISTORY REVIEW, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC THERE WAS AN ISSUE WITH LEAKAGE ON THE SECOND DAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT UNDERWENT PAINLESS UTERINE CURETTAGE ON (B)(6) 2019 BECAUSE OF EARLY PREGNANCY AND ABORTION. THE INTRAVENOUS CHANNEL WAS ESTABLISHED BY INDWELLING NEEDLE BEFORE OPERATION, AND THE CATHETER WAS SEALED BY ROUTINE INDWELLING NEEDLE AFTER THE COMPLETION OF FLUID INFUSION ON THAT DAY. DURING INTRAVENOUS INFUSION ON (B)(6) LEAKAGE OF THE TAIL OF THE INDWELLING NEEDLE WAS FOUND AND COULD NOT BE CONTINUED. RE-PUNCTURE WITH ONE-TIME INFUSION AFTER REMOVAL OF INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    920661 INTIMA-II Y 18GAX1.16IN PRN EC SLM NPVC CATHERTER FOZ BD (SUZHOU) 8171129

    Patients

    Seq Age Sex Outcome Treatment
    1 Other