BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 12044964 · Received June 22, 2021

    Report

    Report Number
    3006948883-2021-00700
    Event Type
    Malfunction
    Date Received
    June 22, 2021
    Date of Event
    May 16, 2021
    Report Date
    June 8, 2021
    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 · 1

    INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050858. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM SEPARATED FROM THE NEEDLE HUB DURING THE ATTEMPTED PUNCTURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "THE CHILD WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2021 DUE TO "FEVER FOR 4 DAYS AND RASH FOR HALF A DAY", AND WAS DIAGNOSED AS BRONCHOPNEUMONIA. INTRAVENOUS INFUSION WAS GIVEN AFTER ADMISSION. IN ORDER TO PROTECT BLOOD VESSELS AND REDUCE THE NUMBER OF PUNCTURE TIMES, A CLOSED VEIN INDWELLING NEEDLE WAS USED FOR PUNCTURE AND INFUSION. ON (B)(6) 2021 WHEN THE CLOSED VEIN INDWELLING NEEDLE WAS USED FOR VENIPUNCTURE OF THE CHILD, THE NEEDLE HEAD OF THE INDWELLING NEEDLE WAS NOT EASY TO ENTER THE NEEDLE, AND THE SEPARATION OF THE CATHETER TUBE AND NEEDLE LED TO THE PUNCTURE FAILURE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    937053 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0357696

    Patients

    Seq Age Sex Outcome Treatment
    1