BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 12913603 · Received December 1, 2021

    Report

    Report Number
    3014704491-2021-00312
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    September 25, 2021
    Report Date
    November 11, 2021
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050044 . 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. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INTIMA-II 24GAX0.75IN PRN SLM NPVC, THE DEVICE EXPERIENCED A MISSING PRN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 DUE TO "UPPER ABDOMINAL PAIN, NAUSEA, AND VOMITING FOR 7 DAYS". THE ADMISSION DIAGNOSIS WAS ACUTE EROSIVE GASTRITIS. AFTER ADMISSION, HE WAS GIVEN INTRAVENOUS INFUSION THERAPY. IN ORDER TO REDUCE THE NUMBER OF PUNCTURES, INTRAVENOUS INDWELLING NEEDLES WERE USED. IN THE PROCESS OF INDWELLING THE VENOUS INDWELLING NEEDLE FOR THE PATIENT ON THE (B)(6) 2021, IT WAS FOUND THAT THE CLOSED VENOUS INDWELLING NEEDLE HAD NO PRN AND COULD NOT BE USED. THE CLOSED VENOUS INDWELLING NEEDLE SHOULD BE REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1811107 INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 1050044

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown