BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN

    MDR report key: 20185925 · Received September 10, 2024

    Report

    Report Number
    3014704491-2024-00070
    Event Type
    Malfunction
    Date Received
    September 10, 2024
    Date of Event
    May 27, 2024
    Report Date
    October 23, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    PMA / PMN Number
    K200891
    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. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. WE CANNOT CONFIRM WHETHER THE YELLOW SHANK HEAD REFERS TO THE PP CONNECTOR OR THE SLEEVE STOPPER OF THE PRN, AND WE CANNOT CONFIRM THE STATUS AND COMPOSITION OF THE BLACK SPOT. 2. DHR/BHR REVIEW LOT#: 3171582 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN JULY 2023 AND PACKAGED AT R240 PACKAGE LINE IN JULY 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. 3. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO BLACK SPOTS ARE FOUND. PLEASE SEE ATTACHMENT FOR THE INSPECTION REPORT. 4. THE PLANT HAS RECEIVED A COMPLAINT OF A BLACK SPOT IN THE PP CONNECTOR. AFTER INSPECTION AND ANALYSIS BY THE PP CONNECTOR MANUFACTURING ENGINEER, IT WAS DETERMINED THAT THE BLACK SPOT IS NOT DIRTY, BUT THE MOLDING DEFECT OF THE PP CONNECTOR. BECAUSE THE SEALING RING OF THE HOT RUNNER CYLINDER WAS DAMAGED, THE AIR LEAKAGE CAUSED INSUFFICIENT AIR PRESSURE TO COMPLETELY DRIVE THE VALVE PIN IN PLACE, CAUSING THE VALVE PIN TO STICK MATERIAL, AND INSUFFICIENT MATERIAL TO ENTER THE MOLD CAVITY, RESULTING IN THE BLACK SPOT AT THE PP CONNECTOR. ACTIONS TAKEN: REPLACE THE SEALING RING OF THE HOT RUNNER CYLINDER EVERY 6 MONTHS AND MODIFY THE DOCUMENT MFG-0038-K. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES. BECAUSE THE SPECIFIC SITE OF THE BLACK SPOT AND ITS STATUS AND COMPOSITION CANNOT BE CONFIRMED, THE ROOT CAUSE OF THE DEFECT 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 THE BD INTIMA-II Y 24GAX0.75IN PRN HAD FOREIGN MATTER (MOLD). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024 10:00:00 THE NURSE ON DUTY IN THE WARD FOR THE PATIENT'S INTRAVENOUS INDWELLING NEEDLE PUNCTURE Q, OPEN THE PACKAGE AND FOUND THAT THE CLOSED TYPE INTRAVENOUS INDWELLING NEEDLE (24G * 0.75IN) YELLOW SHANK PART OF THE HEAD OF THE MOLD-LIKE BLACK SPOTS, AND IMMEDIATELY REPLACED WITH ANOTHER CLOSED TYPE INTRAVENOUS INDWELLING NEEDLE (24G * 0.75IN), THE YELLOW SHANK PART OF THE HEAD OF THE NORMAL, CAN BE USED NORMALLY, THE REPORT OF THE ADVERSE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331547 BD INTIMA-II Y 24GAX0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3171582 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown