BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA Y ADP PNK 20GA X 1.0IN

    MDR report key: 22437782 · Received July 8, 2025

    Report

    Report Number
    3006948883-2025-00272
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 14, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903833184
    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

    DHR REVIEW: THE COMPLAINT LOT# IS 4081401, SKU IS 383318, ASSEMBLY IN SUZHOU PLANT ON 2024.MAR.29, 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: ONE PICTURE PROVIDED AND SHOWN THE NEEDLED IS EXPOSED, BUT ALL SHEATH STATUS IS GOOD. RETAIN SAMPLE ANALYSIS: SAMPLING 2EA FROM THE RETAIN SAMPLE OF THE SAME LOT TO CHECK PRODUCT FUNCTION, PRODUCT SAFETY SHIELD ACTIVATION FUNCTION IS GOOD. REFER TO THE ATTACHMENT FOR RETAIN SAMPLE TEST REPORT. POSSIBLE CAUSE ANALYSIS: BASED ON THE REPORTED INFORMATION, NEEDLE IS EXPOSURE TO AIR. POSSIBLE REASONS FOR THIS TYPE OF FAILURE MAY INCLUDING: 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. THESS RISK WILL CAUSE THE OUTER SHIELD DROPS OFF BEFORE THE NEEDLE RETRACTED COMPLETELY. CURRENT MANUFACTURE ALREADY HAS CONTROL PROCEDURES AS BELOW TO DEFECT AND PREVENT THIS KIND OF DEFECT: 1. 100% INSPECTION FOR THE GAP BETWEEN OUTER 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. ONE PICTURE PROVIDED AND SHOWN THE NEEDLED IS EXPOSED, BUT ALL SHEATH STATUS IS GOOD, WITHOUT THIS, WE CANNOT IDENTIFY THE ACTUAL DEFECT FEATURE, 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, HOLD THE PULLER AND KEEP THE COMPONENT ADOWN CAN ACTIVATE NEEDLE SAFETY FUNCTION SUCCESSFULLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SAF-T-INTIMA Y ADP PNK 20GA X 1.0IN SAFETY MECHANISM FAILED FAILURE TO ACTIVATE THE SAFETY SYSTEM AND POSSIBILITY OF BLOOD CONTACT WITH THE OPERATOR. BEFORE USE THE SAFETY SYSTEM DOES NOT ACTIVATE AND THE SPINDLE REMAINS UNCOVERED, WITH A RISK OF ACCIDENTAL PUNCTURE AND BLOOD CONTAMINATION OF THE HEALTHCARE OPERATOR'S HANDS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373967 BD SAF-T-INTIMA Y ADP PNK 20GA X 1.0IN INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081401 00382903833184

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown