BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21170349 · Received January 16, 2025

    Report

    Report Number
    3002601200-2024-00826
    Event Type
    Malfunction
    Date Received
    January 16, 2025
    Date of Event
    December 16, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. NO DEFECTIVE SAMPLE OR PHOTO IS RECEIVED, AND THE FLOCCULENT AT THE TIP OF THE NEEDLE CANNOT BE RECOGNIZED. 2. DHR/BHR REVIEW LOT # 4243786. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEPTEMBER 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN SEPTEMBER 2024. 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 FOREIGN MATTERS ARE FOUND AT THE TIP OF THE NEEDLES. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PRODUCTION PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. BECAUSE THE DEFECTIVE SAMPLE IS NOT RETURNED, THE SPECIFIC STATE AND COMPOSITION OF THE FLOCCULENT AT THE TIP OF THE NEEDLE CANNOT BE CONFIRMED, SO THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM HAD FOREIGN MATTER . THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) AT 11:54 FOR ¿RECURRENT LEFT NASAL BLEEDING FOR 1 DAY¿, EXAMINATION: T36.5C, P80 BEATS/MIN, R20 BEATS/MIN, BP120/80MMHG, CHRONIC CONGESTION OF THE MUCOUS MEMBRANE OF THE LEFT SIDE OF THE NASAL CAVITY, THE LEFT SIDE OF THE NASAL SEPTUM WAS DEVIATED, ¿SPINY¿ DEVIATION, THE LEFT SIDE OF THE RICCI AREA CAN BE SEEN MUCOUS MEMBRANE CONGESTION AND EROSION, A BLEEDING SPOT CAN BE SEEN LOCALLY, THERE IS ACTIVE BLOOD SEEPAGE. ¿LIKE DEVIATION, THE LEFT SIDE OF THE RI'S AREA CAN BE SEEN MUCOSAL CONGESTION AND EROSION, LOCALLY VISIBLE AS A BLEEDING POINT, THERE IS ACTIVE OOZING OF BLOOD, ACCORDING TO THE PATIENT'S CONDITION, AT 14:23 IN ACCORDANCE WITH THE MEDICAL ADVICE GIVEN TO THE INTRAVENOUS INFUSION TREATMENT, INFUSION HAS BEEN CHECKING THE OPERATION OF VARIOUS CONSUMABLES, THE LINE OF SKIN PUNCTURE FOUND THAT THERE IS FLOCCULENT AT THE TIP OF THE NEEDLE TIP OF THE RETENTION NEEDLE, IMMEDIATELY STOP THE INFUSION, REPLACEMENT OF RETENTION NEEDLES, THE INFUSION OF FLUIDS IS FLUENT, THE PATIENT HAS NOT COMPLAINED OF DISCOMFORT. THE PATIENT DID NOT COMPLAIN OF DISCOMFORT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1791149 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4243786 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown