BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN

    MDR report key: 22829859 · Received August 18, 2025

    Report

    Report Number
    3006948883-2025-00492
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 10, 2025
    Report Date
    August 30, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    UDI-DI
    00382903833238
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT 4171437, SKU IS 383323, ASSEMBLY IN SUZHOU PLANT 1 ON 2024. JUL. 5, LOT QUANTITY IS (B)(4) EA. 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 PICTURES PROVIDED TO SHOW DEFECT FEATURE. RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK CATHETER STATUS AND TUBING STATUS, NO DEFECT DETECTED, LEAKAGE TEST RESULT IS WITHIN SPECIFICATION AS WELL. 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. CONCLUSION(S): 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, NO DEFECT DETECTED. WITH THIS WE CANNOT DECIDE THE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD AS THE DATE OF THE EVENT IS UNKNOWN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN -CATHETER DEFECTIVE / DAMAGED. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. STARTED 22 GAUGE IV ON PATIENT FOR LABS AND TREATMENT. WHEN REMOVING THE GUIDEWIRE IV STARTED LEAKING. UPON INSPECTION THERE WAS A HOLE IN THE TUBING. PRODUCT#: 383323. LOT#: 4171437.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2133519 SAF-T-INTIMA W/Y ADAPTER BL 22GA X .75IN INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 4171437 00382903833238

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown