BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 18432318 · Received January 2, 2024

    Report

    Report Number
    3014704491-2023-00866
    Event Type
    Malfunction
    Date Received
    January 2, 2024
    Date of Event
    November 23, 2023
    Report Date
    February 29, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. DHR/BHR REVIEW (LOT#2110889): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2022, AND PACKAGED AT CFS PACKAGE LINE IN MAY 2022. 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 DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. CHECK THE UNIT PACKAGES OF THE RETAINED SAMPLES OF THE COMPLAINT BATCH, NO POOR SEAL IS FOUND. 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 ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. AS THE POOR SEAL STATE OF THE UNIT PACKAGE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, 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 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM PACKAGE SEAL INTEGRITY WAS POOR THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 11.23 REPLACEMENT OF AN INDWELLING NEEDLE WITH A NEEDLE OF THE SAME BATCH NUMBER FOR PATIENT CARE WHEN THE SEAL OF THE OUTER PACKAGE OF THE NEEDLE WAS FOUND TO BE NOT TIGHTLY CLOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1680644 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110889 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown