BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II

    MDR report key: 19924461 · Received August 6, 2024

    Report

    Report Number
    3002601200-2024-00374
    Event Type
    Malfunction
    Date Received
    August 6, 2024
    Date of Event
    June 20, 2024
    Report Date
    September 9, 2024
    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

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

    Additional Manufacturer Narrative · 0

    DHR/BHR REVIEW LOT#4081463. THIS BATCH OF PRODUCTS 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) EA. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. THE CUSTOMER HAS RETURNED A DEFECTIVE SAMPLE, WHICH SHOWS THAT THERE IS BLOOD AT THE SEPTUM. THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE THE DEFECT OF LEAKAGE AT THE SEPTUM. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PRODUCTION PROCESS, AND BLOOD IS FOUND AT THE SEPTUM OF THE RETURNED SAMPLE. TO ADDRESS THE ISSUE OF LEAKAGE AT THE SEPTUM, THE PLANT HAS LAUNCHED CAPA TO TRACK AND INVESTIGATE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II CATHETER KINKED OR BENT DURING INFUSION THE HEAD NURSE OF THE HOSPITAL REPORTED TO THE DISTRIBUTOR THAT WHEN USING AN INDWELLING NEEDLE FOR A NEWBORN, BLOOD RETURNED. THE INDWELLING NEEDLE WAS INSERTED INTO THE BODY ON THE FIRST DAY, AND WAS FOUND TO BE BENT ON THE SECOND DAY. THE SPECIFIC BENDING PART COULD NOT BE CONFIRMED. IT WAS DIFFICULT TO PUSH THE LIQUID WHEN USING THE INDWELLING NEEDLE. THERE WAS A BLOCKAGE. 40 NEEDLES WERE AFFECTED. THE SAMPLES CAN BE RETURNED. THE SPECIFIC NUMBER OF RETURNED NEEDLES CANNOT BE CONFIRMED. PHOTOS CAN BE PROVIDED. A COMPLAINT REPLY LETTER AND A COMPLAINT RECEIPT LETTER ARE REQUIRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592822 BD INTIMA-II INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081463 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown