BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN

    MDR report key: 18049612 · Received November 1, 2023

    Report

    Report Number
    3014704491-2023-00685
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Date of Event
    September 17, 2023
    Report Date
    January 16, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830787
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. H3 OTHER TEXT : SEE NARRATIVE BELOW.

    Additional Manufacturer Narrative · 0

    1.DHR/BHR REVIEW (LOT#3080089): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 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. 2. NO ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED, AND THE STATUS OF THE BLACK IMPURITIES INSIDE THE PRN CANNOT BE IDENTIFIED. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO BLACK IMPURITIES ARE FOUND IN THE PRN, PLEASE SEE ATTACHMENT FOR THE INSPECTION REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLES. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS NO DEFECTIVE SAMPLE IS RECEIVED, THE ROOT CAUSE OF THE BLACK IMPURITIES INSIDE THE PRN CANNOT BE DETERMINED, AND THE PLANT WILL CONTINUE TO FOLLOW UP ON THE COMPLAINT AND FOCUS ON SUCH DEFECTS. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 2 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THERE ARE BLACK FOREIGN MATTERS AT THE ADAPTER OF THE PRN. 2. DHR/BHR REVIEW(LOT#3080089): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN APRIL 2023, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 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 SUCH DEFECTS ARE FOUND, PLEASE SEE ATTACHMENT PR#(B)(4) FOR THE INSPECTION REPORT. 4. THE BLACK FOREIGN MATTERS MAY BE BURNT SPOTS, BUT IT CANNOT BE CONFIRMED AS WE HAVE NOT RECEIVED DEFECTIVE SAMPLE. BURNT SPOTS COME FROM THE MOLDING OF THE ADAPTER. THERE ARE FLOWING BLIND SPOTS IN THE MOLDING MACHINE'S SCREW AND HOT RUNNER SYSTEM OF DIE, AND THE MOLTEN PC IS CARBONIZED INTO BURNT SPOTS IN THESE PLACES AT HIGH TEMPERATURE FOR A LONG TIME. ACTION TAKEN: THE MOLDING MACHINE'S SCREW AND HOT RUNNER SYSTEM OF DIE ARE CLEANED WITH PP EVERY QUARTER TO REDUCE THE OCCURRENCE OF THE BURNT SPOT. 5. IN RESPONSE TO THIS COMPLAINT, TRAINING RELEVANT INSPECTORS TO PAY ATTENTION TO THE REMOVAL OF SIMILAR DEFECTIVE PRODUCTS. PLEASE SEE ATTACHMENT PR#(B)(4) FOR THE TRAINING RECORDS. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTOS SHOW SOME BLACK FOREIGN MATTERS AT THE ADAPTER OF THE PRN. AS NO DEFECTIVE SAMPLE HAS BEEN RECEIVED, THE COMPOSITION OF THE BLACK FOREIGN MATTERS CANNOT BE CONFIRMED AND THEIR SOURCE CANNOT BE ACCURATELY DETERMINED. THE PLANT HAS TRAINED RELEVANT INSPECTORS TO PAY ATTENTION TO THE REMOVAL OF SIMILAR DEFECTIVE PRODUCTS. H3 OTHER TEXT : SEE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN HAD FOREIGN MATTERAT 18:40 ON (B)(6) 2023, A NURSE IN THE ONCOLOGY DEPARTMENT OF (B)(6) HOSPITAL PERFORMED A SELF-CHECK ON THE INDWELLING NEEDLE BEFORE PUNCTURING THE PATIENT. HE FOUND BLACK IMPURITIES INSIDE THE HEPARIN CAP OF THE CLOSED INTRAVENOUS CATHETER AND IMMEDIATELY STOPPED USING IT. THE CLOSED INTRAVENOUS INDWELLING NEEDLE CAN BE USED INSTEAD OF THE ORDINARY CLOSED INTRAVENOUS INDWELLING NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    PHOTOGRAPHS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141298 BD INTIMA-II 24GAX0.75IN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080089 00382903830787

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown