BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

    MDR report key: 17865297 · Received October 3, 2023

    Report

    Report Number
    3014704491-2023-00616
    Event Type
    Malfunction
    Date Received
    October 3, 2023
    Date of Event
    September 16, 2023
    Report Date
    November 17, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    30382903833239
    PMA / PMN Number
    K923702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT# IS 2133278, SKU IS 383323, ASSEMBLY IN SUZHOU PLANT ON 2022.JUL.06, LOT QUANTITY IS (B)(4). REVIEW THE IN PROCESS TEST RECORD AND OUTGOING TEST REPORT, ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS, NO ABNORMAL FOUND. REVIEW THE PRODUCT ASSEMBLY RECORD, NO NON-CONFORMITIES, DEVIATIONS OR REWORK ACTIVITIES FOR THIS LOT RETURNED SAMPLE ANALYSIS: NO RETURNED SAMPLE WAS SENT BACK, AND NO PICTURE OF REPORTED SAMPLE PROVIDED RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO DO LEAKAGE TEST, TEST RESULT IS WITHIN PRODUCT SPECIFICATION. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: BASED ON THE INFORMATION, EXTENSION TUBING LEAKAGE IS REPORTED. THE POSSIBLE REASONS FOR THIS TYPE OF FAILURE MAY INCLUDING: 1. THE CHEMICAL BONDING PERFORMANCE BETWEEN TUBING AND WING IS NOT GOOD, LEAKAGE IS FROM THE BONDING CONNECTOR 2. THE SWAGING BETWEEN LUER-ADAPTER AND TUBING IS NOT GOOD, LEAKAGE IS FROM SWAGING LOCATION 3. TUBING DAMAGE/BROKEN ISSUE (RAW MATERIAL DEFECT INCLUDED), LEAKAGE IS FROM TUBING DIRECTLY CURRENT MANUFACTURE ALREADY HAS CONTROL PROCEDURES AS BELOW TO MONITOR AND PREVENT THIS KIND OF DEFECT: 1. BOTH IN-PROCESS AND OUTGOING SAMPLING WILL CHECK THE PULL FORCE RELATED EXTENSION TUBING, INCLUDING BONDING FORCE AND SWAGING FORCE FOR TWO ENDS, POOR CONNECTION CAN BE DETECTED 2. BOTH IN-PROCESS AND OUTGOING SAMPLING CHECK DO LEAKAGE TEST FOR COMPONENT WITH EXTENSION TUBING THERE IS NO SAMPLE RETURNED, NO DEFECT SAMPLE PICTURE PROVIDED, WITHOUT THIS, THE LEAKAGE LOCATION IS NOT CLEAR, THE ROOT CAUSE IS NOT CLEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHILIE USING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS LEAKAGE. THE FOLLOWING WAS TRANSLATED FROM PORTUGUESE TO ENGLISH: SAF-T-INTIMATE CATHETER 22GAX0.75 0.9X19MM BD REF.383323 - EXTENSION SHOWING A LEAK, BEING REMOVED AND DISPOSED OF DUE TO CONTAMINATION.

    Description of Event or Problem · 0

    SAF-T-INTIMATE CATHETER 22GAX0.75 0.9X19MM BD REF.383323 - EXTENSION SHOWING A LEAK, BEING REMOVED AND DISPOSED OF DUE TO CONTAMINATION. ON 25.SEP.2023, CUSTOMER PROVIDES THE FOLLOWING: WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE? R: AFTER USE. WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? (DETAIL) R: NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) R: NO. WAS THERE EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) R: NO. WHAT MEDICATION WAS BEING ADMINISTERED? R: SALINE SOLUTION. COULD YOU SEND PHOTOS AND/OR VIDEOS THAT SHOW THE DEVIATION IN THE PRODUCT? R: NO. WE WOULD LIKE TO INFORM THAT THE MATERIAL IS NO LONGER AVAILABLE TO BE COLLECTED, SINCE IT HAS BEEN DISCARDED DUE TO THE CONTAMINATION. WE HAVE ITS PACKAGING ONLY. (ADDED ON 17.OCT.2023)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553771 BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2133278 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown