BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM NPVC

    MDR report key: 21562241 · Received March 10, 2025

    Report

    Report Number
    3002601200-2025-00110
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    January 16, 2025
    Report Date
    April 7, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    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. CUSTOMER HAS NO RETURNED SAMPLES, AND RETURNED 1 PHOTO, WHICH SHOWS THAT THE PACKAGE HAS BEEN OPENED, AND THE PRODUCT SPECIFICATION IS 24GA, THE PHOTOGRAPHS SHOW LIMITED INFORMATION, AND COMPLAINT DEFECTS ARE NOT SHOWN. 2. DHR/BHR REVIEW (LOT#: 3080065): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APR 2023 AND PACKAGED AT R240 PACKAGE LINE IN APR 2023. BATCH SIZE WAS (B)(4) EA. 2)REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4)THE CATHETER BATCHES USED IN THIS BATCH OF PRODUCTS IS 3083099, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 3. PERFORMED 45PSI LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. 4. NO SAME COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SAME COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE CRACKING STATE OF THE CATHETER CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS 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

    NO ADDITIONAL INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM NPVC CATHETER WAS DEFECTIVE / DAMAGED PATIENT DIAGNOSED WITH NON-HODGKIN'S LYMPHOMA FOR MORE THAN 6 MONTHS, FOR FURTHER TREATMENT ON (B)(6) 2025 ADMITTED TO THE HOSPITAL FOR TREATMENT, GIVEN TO THE PATIENT TO USE THE CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE, AFTER PUNCTURE, INTO THE HOSE, WITHDRAW THE NEEDLE CORE, FOUND THAT THE FRONT OF THE HOSE OF THE CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE IS CRACKED, IN ORDER TO ENSURE THAT THE EFFECT OF THE PUNCTURE, AND IMMEDIATELY WITHDRAWN THE CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE, REPLACED WITH A NEW CLOSED-TYPE INTRAVENOUS INDWELLING NEEDLE, RESULTING IN SECONDARY INJURIES TO THE PATIENT. TRANSLATED WITH DEEPL.COM (FREE VERSION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254555 BD INTIMA-II 24GAX0.75IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3080065 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown