BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 18553345 · Received January 22, 2024

    Report

    Report Number
    3014704491-2024-00021
    Event Type
    Malfunction
    Date Received
    January 22, 2024
    Date of Event
    November 29, 2023
    Report Date
    March 14, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830572
    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

    1. NO ACTUAL SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW(LOT#3052827): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MARCH 2023, AND PACKAGED AT CFS PACKAGE LINE IN MARCH 2023. WORK ORDER QUANTITY WAS 99,000 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. THIS PRODUCT (SKU 383057) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. FUNCTIONAL TEST (45PSI LEAKAGE TEST) IS CONDUCTED ON THE RETAINED SAMPLE OF THE COMPLAINED BATCH, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE SAMPLE. PLEASE REFER TO THE ATTACHED TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED BECAUSE NO ACTUAL SAMPLE IS RECEIVED, NO FURTHER ANALYSIS CAN BE PERFORMED, AND THE FLOW RATE AND PRESSURE PERFORMED IN THE CTA EXAMINATION OF THE THORACIC AND ABDOMINAL AORTA ARE UNKNOWN. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    A.2. DATE OF BIRTH: UNKNOWN. THE PATIENT¿S AGE WAS USED TO DETERMINE A PLACEHOLDER DATE FOR THIS FIELD. H3. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT INTIMA-II 20GAX1.16IN PRN SLM NPVC LEAKED BLOOD AT INSERTION SITE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: (B)(6), 2023, 15:35, THE PATIENT IS MALE, 71 YEARS OLD, DIAGNOSED WITH AORTIC COARCTATION TYPE B, IN THE CT3 LINE OF THE THORACIC AND ABDOMINAL AORTA CTA EXAMINATION FOR CONTRAST INJECTION, THE NURSE FOUND THAT THE IMAGE OF THE CONTRAST AGENT IS NOT DEVELOPED, IMMEDIATELY STOP THE INJECTION, TO SEE THE PATIENT PUNCTURE SITE IS NOT SWOLLEN PHENOMENON, THE CONTRAST AGENT IS ALL INJECTED IN THE EXAMINATION OF THE BED, AND IMMEDIATELY CHECK THE PLACE OF THE NEEDLE, FOUND THAT THE PATIENT'S BLOOD FROM THE HANDLE OF THE NEEDLE OUT OF THE NEEDLE, AND IMMEDIATELY REMOVED THE NEEDLE AND PRESSED THE PUNCTURE SITE, AND GIVE THE PATIENT TO RE-PUNCTURE THE COMPLETION OF THE EXAMINATION, AND THE PATIENT TO EXPLAIN TO GET THE UNDERSTANDING OF THE PATIENT, DID NOT CAUSE ANY ADVERSE EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052751 INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3052827 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male