BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 22GAX1.00IN PRN SLM NPVC

    MDR report key: 9482839 · Received December 17, 2019

    Report

    Report Number
    3006948883-2019-01100
    Event Type
    Malfunction
    Date Received
    December 17, 2019
    Date of Event
    November 26, 2019
    Report Date
    January 2, 2020
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050835. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. 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 INTIMA-II 22GAX1.00IN PRN SLM NPVC EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INTRAVENOUS INDWELLING NEEDLE WAS BLOCKED WHEN THE PATIENT USED THE INTRAVENOUS INDWELLING NEEDLE TO INJECT THE LIQUID, AND THE INFUSION COULDN'T BE PERFORMED. THE NURSE REMOVED THE INDWELLING NEEDLE AND REPLACED IT WITH OTHER INDWELLING NEEDLES TO RE-INJECT THE PATIENT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II 22GAX1.00IN PRN SLM NPVC EXPERIENCED PRODUCT DAMAGE/DEFORMATION WHILE STILL CONSIDERED OPERABLE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE INTRAVENOUS INDWELLING NEEDLE WAS BLOCKED WHEN THE PATIENT USED THE INTRAVENOUS INDWELLING NEEDLE TO INJECT THE LIQUID, AND THE INFUSION COULDN'T BE PERFORMED. THE NURSE REMOVED THE INDWELLING NEEDLE AND REPLACED IT WITH OTHER INDWELLING NEEDLES TO RE-INJECT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1279957 INTIMA-II 22GAX1.00IN PRN SLM NPVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9050835

    Patients

    Seq Age Sex Outcome Treatment
    1 Other