BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II CLOSED IV CATHETER SYSTEM

    MDR report key: 11691185 · Received April 19, 2021

    Report

    Report Number
    3006948883-2021-00405
    Event Type
    Malfunction
    Date Received
    April 19, 2021
    Date of Event
    March 16, 2021
    Report Date
    March 26, 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 0231286. 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 BLOOD LEAKED FROM BETWEEN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM NEEDLE AND NEEDLE HANDLE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AT 18:00 ON (B)6) 2021, THE CHILD WAS PLACED IN THE EMERGENCY ROOM FOR OBSERVATION DUE TO "ACUTE BRONCHOPNEUMONIA". THE VENOUS ACCESS WAS ESTABLISHED, AND AFTER SUCCESSFUL PUNCTURE, BLOOD LEAKAGE AT THE JUNCTION BETWEEN THE NEEDLE AND THE NEEDLE HANDLE WAS FOUND, SO THE NEEDLE WAS IMMEDIATELY PULLED OUT. AFTER REPLACEMENT, THE PATIENT WAS RE-PUNCTURED, NO HARM WAS CAUSED TO THE CHILD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    581777 BD INTIMA-II CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 0231286

    Patients

    Seq Age Sex Outcome Treatment
    1