BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM-

    MDR report key: 18339181 · Received December 15, 2023

    Report

    Report Number
    3014704491-2023-00819
    Event Type
    Malfunction
    Date Received
    December 15, 2023
    Date of Event
    November 15, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DHR/BHR REVIEW(LOT#3108397): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2023, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2023. WORK ORDER QUANTITY WAS 198,000 EA. 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4)THE PRN BATCH USED IN THIS BATCH OF PRODUCTS IS 3113569, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS ARE RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR LEAKAGE TEST AND PRN REMOVAL TORQUE TEST, THE LEAKAGE TEST IS QUALIFIED, THERE IS NO LEAKAGE AT THE JUNCTION OF THE PP CONNECTOR AND THE PRN, AND THE PRN REMOVAL TORQUE IS WITHIN THE PRODUCT SPECIFICATIONS. (SEE ATTACHMENT FOR THE TEST REPORT) 4. 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 ALARMS AND REMOVES 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 TO PREVENT LEAKAGE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS RETAINED SAMPLE. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. SINCE THE DEFECT STATUS OF THE SAMPLE CANNOT BE IDENTIFIED, AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE LEAKAGE AT THE JUNCTION OF THE PP CONNECTOR AND THE PRN CANNOT BE DETERMINED.

    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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED AT LUER CONNECTION THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; ON (B)(6) 2023, THE NURSE FOUND THAT THE Y-TYPE INTERFACE OF THE INDWELLING NEEDLE AND THE HEPARIN CAP (THE HEPARIN CAP COMES WITH THE INDWELLING NEEDLE) WERE NOT AIRTIGHT AND THERE WAS LEAKAGE WHEN THE NURSE GAVE THE PATIENT AN INFUSION BY PUNCTURING THE INDWELLING NEEDLE, SO THE NURSE IMMEDIATELY REPLACED THE NEW SINGLE-USE HEPARIN CAP WITH A NEW ONE (REPLACED WITH SHANDONG WEIGAO'S), WHICH WAS NORMAL AFTER THE REPLACEMENT AND NO LONGER LEAKED LIQUID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301981 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM- INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3108397 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown