BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA PRN BL 22GA X 0.75IN

    MDR report key: 23694902 · Received December 2, 2025

    Report

    Report Number
    3006948883-2025-00914
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    October 22, 2025
    Report Date
    February 2, 2026
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR REVIEW: THE COMPLAINT LOT IS 5021749, SKU IS 383328, ASSEMBLY IN SUZHOU PLANT ON 2025 FEB 19, LOT QUANTITY IS (B)(4). REVIEW THE IN-PROCESS TEST RECORD AND OUTGOING TEST REPORT FOR ABOVE TWO LOTS, 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: 4 PICTURES PROVIDED AND SHOWS THE CANNULA IS RETRACKED IN CATHETER AND WAS SERIOUS BENT. RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK NEEDLE AND CATHETER ASSEMBLY STATUS, CHECK LIE DISTANCE, ALL TEST RESULTS ARE WITHIN PRODUCT SPECIFICATION. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, CUSTOMER FOUND THE NEEDLE IS RETRACKED IN THE CATHETER AFTER OPENING THE UNIT PACKAGE AND CANNOT BE OPERATED FOR PUNCTURE. POSSIBLE REASONS FOR THIS TYPE OF FAILURE MAY INCLUDING: 1.LIE DISTANCE SETTING IS NOT CORRECT DURING ASSEMBLY. 2.LIE DISTANCE IS CHANGED DURING THE FOLLOWING MANUAL ASSEMBLY FLOW OR MANUAL PACKAGING AFTER LIE DISTANCE PRECISE SETTING. 3. AN INCORRECT OPERATION DURING OPENING THE UNIT PACKAGE, FOR INSTANCE, TAKING OUT THE PRODUCT WITHOUT FULLY PEELING OFF THE PAPER, THE WING-INSERTER WAS STUCK AND CAUSED THE CANNULA TO RETRACK INTO CATHETER. CURRENT MANUFACTURE ALREADY HAS CONTROL PROCEDURES AS BELOW TO DETECT AND PREVENT THIS KIND OF DEFECT: 1.100% INSPECTION FOR LIE DISTANCE DURING ALL PROCESS STATION AFTER LIE DISTANCE PRECISE SETTING. 2. BOTH IN-PROCESS AND OUTGOING SAMPLING CHECK WILL INSPECT LIE DISTANCE. WITH THIS INFORMATION WE CANNOT IDENTIFY WHICH STEP HAVE CAUSED SUCH ISSUE, THIS TYPE OF ANOMALY CANNOT RULE OUT THE POSSIBILITY THAT IT WAS CAUSED BY IMPROPER UNPACKING OPERATIONS DURING TERMINAL USE. THE RETAIN SAMPLE CHECK RESULT ARE ALL WITHIN PRODUCT SPECIFICATIONS, SO WE CANNOT IDENTIFY THE ROOT CAUSE FOR THIS LIE DISTANCE ISSUE.

    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

    IT WAS REPORTED THAT BD SAF-T-INTIMA PRN BL 22GA X 0.75IN PREMATURE NEEDLE RETRACTION WHEN DID THE INCIDENT OCCUR? DURING USE IT WAS REPORTED THAT WHEN REMOVING THE SAFE-T-INTIMA MICROCATHETER FROM ITS STERILE PACKAGING, THE PLASTIC SAFETY MANDREL HAD ALREADY BEEN REMOVED AND THE CANULA RETRACTED, MAKING IT IMPOSSIBLE TO INSERT THE CATHETER SUBCUTANEOUSLY BECAUSE THE CANULA WAS ALREADY IN SAFETY MODE. CLINICAL CONSEQUENCE: NONE, CATHETER REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912518 BD SAF-T-INTIMA PRN BL 22GA X 0.75IN INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 5021749

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown