BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20502170 · Received October 22, 2024

    Report

    Report Number
    3002601200-2024-00534
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 15, 2024
    Report Date
    September 25, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830831
    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

    DHR BHR REVIEW LOT 4081458. 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2024 AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4). 2. REVIEW THE IN PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MET THE PRODUCT SPECIFICATIONS. 3. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4. THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM, CAPA 1044260. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. AS THE PLANT RECEIVED SIMILAR COMPLAINTS FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, 800MM SIMULATED CLINICAL LEAKAGE TEST WAS CONDUCTED ON THE RETAINED SAMPLES OF THIS BATCH, AND IT WAS FOUND THAT A FEW SAMPLES LEAKED AT THE END OF THE SEPTUM AFTER THE NEEDLE TIP WAS INSERTED INTO THE TEST DEVICE, AND THE LEAKAGE STOPPED AFTER THE NEEDLE CORE WAS PULLED OUT. CONCLUSIONS: NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS. IN RESPONSE TO LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE, CAPA 1044260.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC LEAKED AT SEPTUM. AT 16:40 ON (B)(6) 2024, A CHILD WITH NEONATAL PNEUMONIA REQUIRED AN INTRAVENOUS INFUSION OF AMBROXOL HYDROCHLORIDE TO RESOLVE SPUTUM, AND THE NURSE USED A CLOSED INTRAVENOUS INDWELLING NEEDLE WITH A QUESTIONABLE DEVICE TO PLACE AN INTRAVENOUS CANNULA, AND AFTER WITHDRAWING THE NEEDLE, FOUND THAT THE END OF THE ISOLATION PLUG SHOWED A LOT OF BLOOD, WHICH WAS CLEANED UP TO REMOVE THE BLOOD IN THE PORT AND INJECTED SALINE TO FLUSH THE CANNULA INTRAVENOUSLY. WHETHER THERE IS FLUID LEAKAGE FROM THE ISOLATION PLUG. BECAUSE OF THE ABNORMAL PERFORMANCE OF THE ISOLATION PLUG WITH BLOOD RETURN, IT PROVES THAT ITS TIGHTNESS IS POOR, AND IT IS EASY TO INCREASE THE RISK OF CATHETER-RELATED BLOODSTREAM INFECTIONS DURING THE USE OF THE CATHETER, SO IT WAS GIVEN TO CONTINUE TO CLOSELY OBSERVE THE SITE OF THE CHILD'S CATHETERIZATION WITH OR WITHOUT SIGNS OF INFECTION, AND FOR THE TIME BEING, NO INFECTION WAS FOUND, WHICH DID NOT HAVE ANY ADVERSE CONSEQUENCES FOR THE CHILD. NOW REPORTED TO THE MEDICAL CONSUMABLES SECTION, SO THAT THE MANUFACTURER TO IDENTIFY THE EXISTENCE OF THIS BATCH OF PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346391 BD INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR ADMINISTRATION SET FOZ BD SUZHOU (MDS) 4081458 00382903830831

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown