BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23694881 · Received December 2, 2025

    Report

    Report Number
    3006948883-2025-00913
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 11, 2025
    Report Date
    January 30, 2026
    Manufacturer
    BECTON DICKINSON
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION B5: CORRECTION - NO NEEDLESTICK INJURY. SECTION H: HEALTH EFFECT - CLINICAL CODE (ANNEX E) AND HEALTH EFFECT - IMPACT CODE (ANNEX F) UPDATED BASED ON THE CORRECTION. INVESTIGATION RESULTS: DHR REVIEW: THE COMPLAINT LOT# IS 5113203, SKU IS 383319, ASSEMBLY IN SUZHOU PLANT ON 2025.MAY.6, 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: AN UNUSED UNIT FROM THE SAME BATCH AS THE COMPLAINT UNIT WAS RETURNED. DEVICE APPEARED NORMAL. REMOVED DEVICE FROM PACKAGING AND SUCCESSFULLY WITHDREW THE NEEDLE ACTIVATING THE SAFETY DEVICE IN THE PROCESS. RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAINED SAMPLES OF THE SAME LOT TO CHECK PRODUCT FUNCTION, PRODUCT SAFETY SHIELD ACTIVATION FUNCTION IS GOOD. POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, NEEDLE IS EXPOSED TO AIR. POSSIBLE REASONS FOR THIS TYPE OF FAILURE MAY INCLUDE: 1. THE ASSEMBLY STATUS BETWEEN OUTER SHIELD AND RUBBER IS NOT GOOD, THE RUBBER IS NOT PRESSED TO THE END DURING ASSEMBLY. 2. PRODUCT SAFETY SHIELD IS PULLED DURING MANUAL ASSEMBLY FLOW OR MANUAL PACKAGING. THESE WILL CAUSE THE OUTER SHIELD TO DROP OFF BEFORE THE NEEDLE RETRACTED COMPLETELY. CURRENT MANUFACTURING ALREADY HAS CONTROL PROCEDURES AS BELOW TO DETECT AND PREVENT THIS KIND OF DEFECT: 1. 100% INSPECTION FOR THE GAP BETWEEN OUTER SHIELD AND RUBBER IS PERFORMED AT THE LAST STATION OF ASSEMBLY. 2. BOTH IN-PROCESS AND OUTGOING SAMPLING CHECK WILL TEST THE SEPARATION FORCE BETWEEN RUBBER AND OUTER SHIELD. CONCLUSION(S): AS WE COULD NOT OBSERVE THE ACTUAL DEFECT FEATURE IN THE RETURNED AND RETAINED SAMPLES, CANNOT DETERMINE WHETHER IT¿S A POOR ASSEMBLY ISSUE OR RAW MATERIAL ISSUE. SO, THE ROOT CAUSE OF THIS CASE IS NOT CLEAR. BASED ON THE IFU DESCRIPTION, IF THE SAFETY SHIELD DOES NOT ACTIVATE, HOLDING THE PULLER WITH NEEDLE TIP POINTED DOWN AND GENTLY PUSHING THE TELESCOPING NEEDLE SHIELD DOWNWARD CAN ACTIVATE NEEDLE SAFETY FUNCTION SUCCESSFULLY; NEEDLE CAN BE RETRACTED INTO THE SAFETY SHIELD.

    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

    CORRECTION: NO NEEDLESTICK INJURY.

    Description of Event or Problem · 0

    WHEN PULLING OUT THE GUIDE WIRE THE SHARP WAS REMOVED FROM THE SAFETY SHEATH AND POSED A NEEDLE STICK INJURY TO THE HEALTHCARE PROFESSIONAL INSERTING THE DEVICE. THIS DOES NOT USUALLY OCCUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2783295 SAF-T-INTIMA Y ADP YEL 24GA X 0.75IN ROW INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5113203

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown