BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC

    MDR report key: 20567319 · Received October 30, 2024

    Report

    Report Number
    3002601200-2024-00566
    Event Type
    Malfunction
    Date Received
    October 30, 2024
    Date of Event
    September 30, 2024
    Report Date
    November 22, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830626
    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

    1. THE CUSTOMER RETURNED 1 PHOTO AND 2 DEFECTIVE SAMPLES. 1-THE PHOTO SHOWS BLOOD OOZING FROM THE END OF THE SEPTUM. 2-THE DEFECTIVE SAMPLES SHOW THAT THE PINHOLES AT THE END OF THE SEPTUM ARE NOT CLOSED; LIQUID CAN LEAK THROUGH UNCLOSED PINHOLES; THE PRODUCTS ARE DISSECTED, AND NO ASSEMBLY PROBLEMS ARE FOUND, SUCH AS THE SEPTUM IS INVERTED, OR THE CANNULA DOES NOT PASS THROUGH THE PRE-OPENING HOLE. PLEASE SEE THE ATTACHMENT PR#(B)(4)-1 FOR PHOTOS. 2. DHR/BHR REVIEW LOT#4052078 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS 198,000 EA. 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-DUE TO SIMILAR COMPLAINTS RECEIVED FROM OTHER BATCHES OF PRODUCTS, THE PLANT HAS LAUNCHED CAPA TO INVESTIGATE THE LEAKAGE AT THE SEPTUM. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR RELATED TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST. ALL SAMPLES PASS THE TEST, AND NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHMENT PR#(B)(4) FOR TEST REPORTS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTO AND SAMPLES SHOW LEAKAGE AT THE SEPTUM. IN RESPONSE TO THIS DEFECT, THE PLANT HAS LAUNCHED CAPA TO TRACE AND INVESTIGATE ITS ROOT CAUSE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC LEAKED AT SEPTUM. THERE IS BLOOD LEAKAGE AT THE CONNECTION SEAT DURING USE. YOU CAN RETURN THE DEFECTIVE PRODUCT WITHOUT A CLAIM. YOU NEED A COMPLAINT RESPONSE LETTER AND A COMPLAINT ACCEPTANCE LETTER.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED. 1. IS THE DEVICE DAMAGED DURING USE? IF SO, AT WHAT APPROXIMATE LOCATION? UNDAMAGED 2. IS THE INSTRUMENT USED FOR MULTIPLE PUNCTURES? NOPE 3. DO YOU USE A SYRINGE TO INJECT LIQUID THROUGH AN INSTRUMENT? YES ** NO ADDITIONAL INFORMAITON PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1964779 BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052078 00382903830626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown