BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 20788518 · Received November 26, 2024

    Report

    Report Number
    3002601200-2024-00658
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    October 29, 2024
    Report Date
    December 9, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830077
    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. DHR/BHR REVIEW LOT#4081482. 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 99,000 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. 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED TESTING: 800MM SIMULATED CLINICAL LEAKAGE TEST. THE TEST IS PASSED, AND NO LEAKAGE IS FOUND AT THE SEPTUM. PLEASE SEE THE ATTACHED TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECT STATUS OF THE COMPLAINED SAMPLE CAN BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 20GAX1.16IN PRN SLM LEAKAGE AT SEPTUM DURING USE OF THE PRODUCT, THERE WAS BLEEDING AND OOZING FROM THE ISOLATION PLUG; THE AFFECTED QUANTITY WAS 1 PLUG, THE SAMPLE CANNOT BE RETURNED, AND A PHOTO IS PROVIDED; A GREEN CLAIM IS REQUIRED, AND A COMPLAINT RESPONSE LETTER AND COMPLAINT ACCEPTANCE LETTER ARE NOT REQUIRED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION PROVIDED 11/22/2024 1. PLEASE PROVIDE PICTURE / VIDEO / PHYSICAL SAMPLE IF AVAILABLE. A: NO SAMPLES RETURNED. 2. THE BATCH NUMBER PROVIDED FOR THE RESPECTIVE MATERIAL NUMBER DO NOT MATCH IN SAP, PLEASE PROVIDE A VALID MATERIAL AND BATCH NUMBER. A: ITEM NUMBER: 383012, BATCH NUMBER: 4081482. NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    878604 BD INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4081482 00382903830077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown