BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 9526115 · Received December 27, 2019

    Report

    Report Number
    3006948883-2019-01128
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 4, 2019
    Report Date
    January 16, 2020
    Manufacturer
    BD (SUZHOU)
    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 SUMMARY BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, NO ISSUES WERE OBSERVED RELATING TO LEAKAGE AS ALL RETENTION SAMPLES MET SPECIFICATIONS. A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9050923. 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. BD WILL CONTINUE TO MONITOR THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS ADMITTED TO HOSPITAL FOR TREATMENT OF INFUSION AND ANTI-INFECTION DUE TO CHRONIC BRONCHITIS. WHEN THE NURSE WAS ADMINISTERING THE INFUSION, SHE FOUND THAT THE LIQUID HAD ENTERED THE NEEDLE JOINT AND WAS LEAKING, AND IMMEDIATELY REPLACED THE NEEDLE¿

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE OF THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS AN ISSUE WITH LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: THE PATIENT WAS ADMITTED TO HOSPITAL FOR TREATMENT OF INFUSION AND ANTI-INFECTION DUE TO CHRONIC BRONCHITIS. WHEN THE NURSE WAS ADMINISTERING THE INFUSION, SHE FOUND THAT THE LIQUID HAD ENTERED THE NEEDLE JOINT AND WAS LEAKING, AND IMMEDIATELY REPLACED THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1322782 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 9050923

    Patients

    Seq Age Sex Outcome Treatment
    1 Other