BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 12305111 · Received August 10, 2021

    Report

    Report Number
    3014704491-2021-00072
    Event Type
    Malfunction
    Date Received
    August 10, 2021
    Date of Event
    July 12, 2021
    Report Date
    August 18, 2021
    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 · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1032192. 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. ALTHOUGH PHOTOS WERE SUBMITTED FOR EVALUATION, THE AFFECTED 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. BASED ON THE PROVIDED INFORMATION THE MOST LIKELY ROOT CAUSE FOR THIS EVENT IS RELATED TO THE PATIENT'S APPLICATION OF FORCE TO THE DEVICE. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO CONFIRM THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM TUBING WAS ACCIDENTALLY PULLED BY THE PATIENT, SEPARATING IT FROM THE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "AT 3:00 A.M. ON (B)(6) 2021, THE PATIENT ACCIDENTALLY PULLED THE INDWELLING NEEDLE DURING HOSPITALIZATION. THE CATHETER TUBE AND Y-SHAPED CATHETER SEAT OF THE INDWELLING NEEDLE FELL OFF, AND THE NURSE PULLED OUT THE NEEDLE. NO HARM WAS CAUSED TO PATIENTS"

    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 BD INTIMA-II CLOSED IV CATHETER SYSTEM TUBING WAS ACCIDENTALLY PULLED BY THE PATIENT, SEPARATING IT FROM THE ADAPTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AT 3:00 A.M. ON (B)(6) 2021, THE PATIENT ACCIDENTALLY PULLED THE INDWELLING NEEDLE DURING HOSPITALIZATION. THE CATHETER TUBE AND Y-SHAPED CATHETER SEAT OF THE INDWELLING NEEDLE FELL OFF, AND THE NURSE PULLED OUT THE NEEDLE. NO HARM WAS CAUSED TO PATIENTS"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1199294 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ 1032192

    Patients

    Seq Age Sex Outcome Treatment
    1