BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21149507 · Received January 14, 2025

    Report

    Report Number
    3002601200-2024-00818
    Event Type
    Malfunction
    Date Received
    January 14, 2025
    Date of Event
    December 17, 2024
    Report Date
    May 6, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. NO DEFECT SAMPLE OR PHOTOGRAPH IS RECEIVED, AND THE ABNORMAL STATES AT THE SEPTUM CANNOT BE IDENTIFIED. 2. DHR/BHR REVIEW LOT# 0231225. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEPTEMBER 2020, AND PACKAGED AT CFS PACKAGE LINE IN SEPTEMBER 2020. 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. THE SHELF LIFE OF THE INDWELLING NEEDLE IS 3 YEARS. RETAINED SAMPLE ANALYSIS IS NOT PERFORMED AS THE SHELF LIFE OF THIS BATCH OF PRODUCTS HAS EXPIRED. 4. LEAKAGE AT THE SEPTUM MAY GENERALLY OCCUR AFTER THE NEEDLE CORE IS WITHDRAWN AND THE PRODUCT IS USED FOR HIGH-PRESSURE INJECTION AND WILL NOT OCCUR ON THE THIRD DAY OF NORMAL USE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE ROOT CAUSE OF THE LEAKAGE AT THE SEPTUM CANNOT BE DETERMINED BECAUSE NO ABNORMALITY IS FOUND ON PRODUCTION PROCESS, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TESTING, AND THE USE OF THE SAMPLE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    A COMPLAINT HISTORY REVIEW CANNOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS PROVIDED. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A RETAIN SAMPLE ANALYSIS COULD NOT BE PERFORMED AS NO BATCH/LOT NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. ROOT CAUSE COULDN'T BE DETERMINED DUE TO UNAVAILABILITY OF SAMPLE AND BATCH/LOT NUMBER INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: AN INDWELLING NEEDLE PLACEMENT WAS PERFORMED ON (B)(6) 2024 AT 15:30 AND AFTER A SMOOTH, INFUSION ON (B)(6) 2024 AT 10:00 WAS NOTED TO BE OOZING SIGNIFICANTLY WITH NO SLIPPAGE OF THE INDWELLING NEEDLE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2012375 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BD SUZHOU (MDS) 0231225 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown