BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA

    MDR report key: 22842309 · Received August 19, 2025

    Report

    Report Number
    3006948883-2025-00499
    Event Type
    Malfunction
    Date Received
    August 19, 2025
    Date of Event
    August 4, 2025
    Report Date
    September 22, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT# 4081414, SKU IS (B)(4), ASSEMBLY IN SUZHOU PLANT1 ON 2024.APR.8, A PLANNED 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. RETURN SAMPLE ANALYSIS: PICTURE PROVIDED AND SHOWING LEAKING ON THE EXTENSION TUBING. RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO DO LEAKAGE TEST, RESULT IS WITHIN SPECIFICATION AS WELL. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, DAMAGE IS DETECTED ON CATHETER AND CAUSE A LEAKAGE, THE POSSIBLE REASON IS AS BELOW: 1. THE RAW MATERIAL HAS DEFECT. 2. COMPONENT DAMAGE HAPPENED DURING ASSEMBLY. CURRENT MANUFACTURE PROCESS HAS 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. WE CANNOT IDENTIFY WHICH STEP CAUSES THE DAMAGE OR IT'S A RAW MATERIAL DEFECT. THE RETAINED SAMPLE APPEARANCE INSPECTION AND LEAKAGE TEST IS PERFORMED, NOT DEFECT DETECTED, WITH THIS WE CANNOT DECIDE THE ROOT CAUSE, ONLY ANALYZE POSSIBLE REASONS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN TUBING WAS DEFECTIVE/DAMAGED IT WAS REPORTED THAT "HOLE IN THE ESXTENSION OF THE DEVICE, THE LEAKING OCCURRED WHEN THE CATETER WAS INSTALLED, ON THE RETURN THERE WAS ALREADY A LEAK, LOT NUMBER 4081414, PRODUCT PURCHASED FROM THE MANUFACTURER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1436319 SAF-T-INTIMA INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081414 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown