BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 16120723 · Received January 9, 2023

    Report

    Report Number
    3014704491-2022-00733
    Event Type
    Malfunction
    Date Received
    January 9, 2023
    Date of Event
    December 8, 2022
    Report Date
    January 17, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2172312. 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.

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A CRACK WAS FOUND IN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, CAUSING LEAKAGE TO OCCUR AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO BURNS, AND WAS GIVEN ANTI-INFLAMMATORY DRUG INFUSION ACCORDING TO THE DOCTOR'S ADVICE. BEFORE THE INJECTION, THE PATIENT WAS PUNCTURED WITH AN INDWELLING NEEDLE. WHEN CHECKING THE AIRTIGHTNESS OF THE INDWELLING NEEDLE, A CRACK WAS FOUND AT THE TRANSPARENT TEE, AND THERE WAS LEAKAGE. ABANDON AND REPLACE THE INDWELLING NEEDLE WITH A NEW ONE, SUCCESSFULLY PUNCTURE THE PATIENT, REPORT TO THE HEAD NURSE AND MAKE A RECORD. THE EVENT DID NOT HARM THE PATIENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CRACK WAS FOUND IN THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM, CAUSING LEAKAGE TO OCCUR AT THE CONNECTION SITE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "ON (B)(6) 2022, THE PATIENT WAS ADMITTED TO THE HOSPITAL DUE TO BURNS, AND WAS GIVEN ANTI-INFLAMMATORY DRUG INFUSION ACCORDING TO THE DOCTOR'S ADVICE. BEFORE THE INJECTION, THE PATIENT WAS PUNCTURED WITH AN INDWELLING NEEDLE. WHEN CHECKING THE AIRTIGHTNESS OF THE INDWELLING NEEDLE, A CRACK WAS FOUND AT THE TRANSPARENT TEE, AND THERE WAS LEAKAGE. , ABANDON AND REPLACE THE INDWELLING NEEDLE WITH A NEW ONE, SUCCESSFULLY PUNCTURE THE PATIENT, REPORT TO THE HEAD NURSE AND MAKE A RECORD. THE EVENT DID NOT HARM THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2306150 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2172312

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown