BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 18988330 · Received March 27, 2024

    Report

    Report Number
    3002601200-2024-00104
    Event Type
    Malfunction
    Date Received
    March 27, 2024
    Date of Event
    February 13, 2024
    Report Date
    April 12, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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

    1. DHR/BHR REVIEW(LOT#3080092): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2023, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)(4) 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 BATCHES USED IN THIS BATCH OF PRODUCTS ARE 3083068, 2328081, 2328082, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN 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 PRN, AND THE PRN REMOVAL TORQUE IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORTS. 4. CAUSE ANALYSIS: 1) 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. 2) BLOOD WAS FOUND TO BE LEAKING FROM THE JOINT BETWEEN THE INDWELLING NEEDLE AND THE PRN, AND THE PRN WAS REPLACED", INDICATING THAT THE LUER OF THE PP CONNECTOR OF THE COMPLAINED SAMPLE WAS NOT DAMAGED AND THE PRN ASSEMBLY WAS NOT MALOCCLUSION. 3) IF THE PRODUCT IS VIBRATED DURING TRANSPORTATION, THE PRN MAY COME LOOSE. 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, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE DEFECTIVE SAMPLE HAS NOT BEEN RECEIVED FOR TESTING AND CONFIRMATION, THE ROOT CAUSE OF THE LEAKAGE FROM THE JOINT BETWEEN THE INDWELLING NEEDLE 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

    ON 2024.2.13, AFTER OPENING THE PATIENT'S VENOUS ACCESS TO THE INDWELLING NEEDLE WAS SUCCESSFULLY OPERATED, BLOOD WAS FOUND TO BE LEAKING FROM THE JOINT BETWEEN THE INDWELLING NEEDLE AND THE HEPARIN CAP, AND THE HEPARIN CAP WAS REPLACED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON (B)(6) 2024, AFTER OPENING THE PATIENT'S VENOUS ACCESS TO THE INDWELLING NEEDLE WAS SUCCESSFULLY OPERATED, BLOOD WAS FOUND TO BE LEAKING FROM THE JOINT BETWEEN THE INDWELLING NEEDLE AND THE HEPARIN CAP, AND THE HEPARIN CAP WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2131058 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3080092 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown