BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN

    MDR report key: 22828099 · Received August 18, 2025

    Report

    Report Number
    3006948883-2025-00487
    Event Type
    Malfunction
    Date Received
    August 18, 2025
    Date of Event
    July 24, 2025
    Report Date
    November 13, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833191
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    IMDRF ANNEX A: THE NOW RETIRED MEDICAL DEVICE PROBLEM CODE A0202 - DEFECTIVE COMPONENT (2292) REPORTED IN THE INITIAL MDR FOR THIS EVENT IS REPLACED WITH A04 - MATERIAL INTEGRITY PROBLEM (2978) IN THIS SUPPLEMENTAL MDR. INVESTIGATION RESULTS: DHR REVIEW: THE COMPLAINT LOT# IS 4171465, ASSEMBLY IN SUZHOU PLANT ON 2024. JUL. 18, A PLANNED 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. RETURNED SAMPLE ANALYSIS: THE DEFECTIVE SAMPLE WAS RETURNED. IMAGING OF THE DEFECT SAMPLE SHOWED A WRINKLED CONDITION OF THE CATHETER DUE TO USE. RETAINED SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME MANUFACTURE LOT TO CHECK PRODUCT CANNULA TIP STATUS; THE CANNULA TIP STATUS IS GOOD AND NO DEFECT DETECTED. THE PUNCTURING FUNCTION IS ALSO WITHIN SPECIFICATION. POSSIBLE CAUSE ANALYSIS: THE REPORTED INFORMATION IS PRODUCT PUNCTURE FAILURE. IT¿S POSSIBLE THAT A BLUNT NEEDLE TIP CAUSED PUNCTURE FAILURE; THE POSSIBLE REASON OF THIS TYPE OF DEFECT WILL BE: 1. INCOMING CANNULA MATERIAL DEFECT. 2. CANNULA TIP WAS DAMAGED BEFORE ASSEMBLING THE NEEDLE COVER DURING ASSEMBLY. CURRENT MANUFACTURING PROCESS HAS THE OPERATIONS AS BELOW TO PREVENT THE RISK ABOVE: 1. 100% INSPECTION FOR INCOMING CANNULA QUALITY BEFORE CANNULA LUBRICATION, THE DEFECT SAMPLE CAN BE IDENTIFIED. 2. 100% PUNCTURE SIMULATION TEST WITH RUBBER FILM DURING FINAL ASSEMBLY (1) PROCESS; PRODUCT WITH DEFECT CANNULA TIP CAN BE IDENTIFIED. CONCLUSION(S): THE RETAINED SAMPLES ARE WITHIN PRODUCT SPECIFICATION. THE DEFECT SAMPLE SHOWED A WRINKLED CONDITION OF THE CATHETER DUE TO USE. WITH THIS INFORMATION THE ROOT CAUSE FOR THIS CASE IS NOT CLEAR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN CATHETER DEFECTIVE / DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, IT WAS REPORTED BY CUSTOMER THAT THEY PRIMED THE SAFETY SYSTEM WITH Y ADAPTER WITH SALINE. UPON INSPECTION OF BEVEL, THERE APPEARED TO BE BUBBLES IN THE CATHLON. ATTEMPTED TO INSERT SAME ON PATIENT WITH NO SUCCESS. UPON REMOVAL OF NEEDLE, CATHLON PLASTIC APPEARS DISINTEGRATED/ ROUGH. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED I RECEIVED THE FOLLOWING PRODUCT REPORT: PRODUCT: 383319, LOT: 4171465, DATE OF INCIDENT: (B)(6) 2025 PATIENT HARM: NO SAMPLE: YES DETAILS: PRIMED THE SAFETY SYSTEM WITH Y ADAPTER WITH SALINE. UPON INSPECTION OF BEVEL, THERE APPEARED TO BE BUBBLES IN THE CATHLON. ATTEMPTED TO INSERT SAME ON PATIENT WITH NO SUCCESS. UPON REMOVAL OF NEEDLE, CATHLON PLASTIC APPEARS DISINTEGRATED/ ROUGH.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590528 BD SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171465 00382903833191

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown