BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 17830757 · Received September 28, 2023

    Report

    Report Number
    3014704491-2023-00601
    Event Type
    Malfunction
    Date Received
    September 28, 2023
    Date of Event
    August 15, 2023
    Report Date
    October 27, 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
    OTHER HEALTH CARE PROFESSIONAL
    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#2292363, SKU IS 383323, ASSEMBLY IN SUZHOU PLANT1 ON 2022.NOV.7, LOT QUANTITY IS 48066EA 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 RETURN SAMPLE ANALYSIS: NO SAMPLE RETURNED, AND THERE ARE 3 PICTURES PROVIDED WHICH SHOW THE SAME APPEARANCE, BUT DOES NOT SHOW THE DEFECT FEATURE RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK PRODUCT APPEARANCE AND DO LEAKAGE TEST, NO DEFECT DETECTED AND TEST RESULT IS GOOD. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, LEAKAGE ISSUE HAPPEN DUE TO PRODUCT COMPONENT DEFECT, HOLE IS DEFECTED ON TUBING, THE POSSIBLE REASON IS AS BELOW: 1. THE RAW MATERIAL HAS DEFECT 2. COMPONENT DAMAGE HAPPENED DURING ASSEMBLY CURRENT MANUFACTURE PROCESS HAVE TAKEN CONTROL PROCEDURES AS BELOW TO PROTECT THIS KIND OF POSSIBLE RISK: 1. 100% COMMON INSPECTION IS PERFORMED DURING EACH PROCESS STATION START FROM TUBING BONDING PROCESS 2. COMMON INSPECTION IS PERFORMED DURING PACKAGING PROCESS 3. QC SAMPLING CHECK WILL INSPECT THE COMPONENT APPEARANCE AND DO LEAKAGE TEST AS CONCLUSION: THERE IS NO SAMPLE RETURNED, THE PICTURES OF THE DEFECT SAMPLE DOES NOT SHOW THE ACTUAL DEFECT FEATURE AS WELL. THE RETAINED SAMPLE APPEARANCE INSPECTION AND LEAKAGE TEST IS PERFORMED, NOT DEFECT FEEDBACK, WITH THIS WE CANNOT DECIDE THE ROOT CAUSE, ONLY ANALYZE POSSIBLE REASON H3 OTHER TEXT : SEE H10

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM HAD HOLES IN IT THAT CAUSED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE: "WHEN THE PATIENT WAS PUNCTURED, HE NOTICED THAT THE ACCESS HAD HOLES AND LEAKAGE, AND THERE WAS A NEED TO REMOVE IT. GOGGLE TRANSLATION: WHEN PUNCTURING THE PATIENT, IT WAS NOTICED THAT THE ACCESS WAS PUNCTURED AND LEAKING, AND IT WAS NECESSARY TO REMOVE IT."

    Description of Event or Problem · 0

    WHEN THE PATIENT WAS PUNCTURED, HE NOTICED THAT THE ACCESS HAD HOLES AND LEAKAGE, AND THERE WAS A NEED TO REMOVE IT. GOGGLE TRANSLATION WHEN PUNCTURING THE PATIENT, IT WAS NOTICED THAT THE ACCESS WAS PUNCTURED AND LEAKING, AND IT WAS NECESSARY TO REMOVE IT. 21.SEPT.23: ADD INFO RECEIVED. WAS THERE ANY HARM TO THE PATIENT/HEALTHCARE PROFESSIONAL? THERE WAS NO DAMAGE, IT JUST HAD TO BE PUNCTURED AGAIN, AS THE LEAK WAS IDENTIFIED EARLY AS SOON AS IT WAS INSTALLED IN THE PATIENT. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO WHAT HAPPENED (IMAGING EXAMS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? THERE WASN'T. WAS THERE EXPOSURE OF BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? THERE WASN'T. IS THE LEAK COMING FROM THE CATHETER BODY, THE ADAPTER CONNECTION OR THE REFLUX CHAMBER? FROM THE CATHETER BODY HAVE YOU NOTICED HOLES AND/OR CRACKS COMING FROM THE REGION WHERE THE LEAK OCCURS? YES A HOLE HAVE YOU NOTICED ANY DAMAGE TO THE PACKAGING OF THE DEVICES? THERE WAS NO DAMAGE TO THE PACKAGING COULD YOU SEND PHOTOS AND/OR VIDEOS THAT SHOW THE DEVIATION IN THE PRODUCT? ATTACHED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741215 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2292363 30382903833239

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown