BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 21551253 · Received March 7, 2025

    Report

    Report Number
    3002601200-2025-00108
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 21, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830077
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCTION RECORD CHECK (LOT#4171024): THIS BATCH OF PRODUCTS WILL BE ASSEMBLED IN JINGMA AUTOMATIC LINE 4 IN JULY 2024 AND PACKAGED IN R240 PACKAGING LINE IN JULY 2024. THE NUMBER OF WORK ORDERS IS (B)(4) PIECES. CHECK THE PROCESS TEST REPORT AND SHIPMENT TEST REPORT, AND THE TEST RESULTS ARE IN LINE WITH PRODUCT STANDARDS. CHECK PRODUCTION RECORDS FOR ANY CONFORMITY, DEVIATION OR REWORK BEHAVIOR. NO ABNORMALITY WAS FOUND IN THE RAW MATERIAL INSPECTION RECORDS OF THE PRN USED IN THIS BATCH OF PRODUCTS. THE CUSTOMER RETURNED A PHOTO WITHOUT RETURNING THE SAMPLE, WHICH SHOWED THAT THE NEEDLE HAD WITHDRAWN, THERE IS RESIDUAL BLOOD ON THE PRN. THE RETAINED SAMPLE OF THIS BATCH WAS TAKEN FOR THE PRN TORQUE FORCE AND 45PSI LEAKAGE TEST. THE SAMPLE TEST RESULT IS OK, AND THE TEST REPORT IS ATTACHED (B)(4). ROOT CAUSE ANALYSIS: IN THE ASSEMBLY PROCESS OF PRN, THERE ARE TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF PRN CAN BE ASSEMBLED INTO THE PP CONNECTOR TO A CERTAIN DEPTH AND THE THREAD HAS A GOOD FASTENING EFFECT. IF THE PRN IS NOT IN PLACE, THE EQUIPMENT WILL ALARM AND REMOVE THE PRODUCT. HOWEVER, ALTHOUGH PRN IS FASTENED TO THE PRODUCT DURING ASSEMBLY, IT MAY COME LOOSE IF IT IS VIBRATED DURING TRANSPORTATION. THEREFORE, THE IFU OF THE PRODUCT INDICATES THAT THE PRN SHOULD BE TIGHTENED BEFORE USE. THE PRN IS ONLY SUITABLE FOR NORMAL PRESSURE (I.E., LESS THAN 45PSI, 310KPA) INFUSION, HIGH PRESSURE INJECTION CAN CAUSE THE SLEEVE STOPPER OF THE PRN TO EXPAND AND EVEN BURST. NO SIMILAR COMPLAINTS ABOUT THIS BATCH OF PRODUCTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS. CONCLUSION: NO ABNORMALITIES WERE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS WERE RECEIVED FROM OTHER HOSPITALS FOR THIS BATCH OF PRODUCTS. SINCE NO SAMPLE RETURNED FROM THE CUSTOMER AND THE USE OF THE SAMPLE WAS UNKNOWN, THE ROOT CAUSE OF THE LEAKAGE AT PRN CAP JOINT COULD NOT BE CONFIRMED. THE LOOSE SEALING CLAMP FROM THE RETURNED PHOTO ANALYSIS MAY BE CAUSED BY THE INAPPROPRIATE POSITION OF THE CUSTOMER'S CLAMP, UNRELATED TO THE FACTORY, WILL CONTINUE TO PAY ATTENTION TO SIMILAR SITUATIONS.

    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

    NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM LEAKED HOSPITAL REPORTED BLOOD LEAKAGE DUE TO INABILITY TO CLAMP THE THUMBTACK WHEN THE INDWELLING NEEDLE WAS PLACED IN THE PATIENT, NUMBER OF UNITS AFFECTED 1 UNIT, SAMPLES COULD NOT BE RETURNED, PHOTOS AVAILABLE, NO GREEN CLAIMS, COMPLAINT RESPONSE LETTER (STAMPED) REQUIRED COMPLAINT RECEIPT LETTER REQUIRED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1098906 BD INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4171024 00382903830077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown