BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN

    MDR report key: 18093347 · Received November 8, 2023

    Report

    Report Number
    3014704491-2023-00719
    Event Type
    Malfunction
    Date Received
    November 8, 2023
    Date of Event
    September 9, 2023
    Report Date
    December 13, 2023
    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#3052734): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6)2023, AND PACKAGED AT R240 PACKAGE LINE IN (B)(4)2023. WORK ORDER QUANTITY WASEA. 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 PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR THE SEALING PRESSURE TEST OF THE PINCH CLAMP (TEST PROCESS: THE PINCH CLAMP CLAMPS THE EXTENSION TUBING AT THE SAME POSITION FOR MORE THAN 64 TIMES, AND THEN THE SAMPLE IS KEPT IN THE CLAMPING STATE OF THE PINCH CLAMP AND KEPT UNDER THE DEVICE WITH 800MM PRESSURE FOR 3 DAYS). TEST RESULTS: NO LEAKAGE OR DAMAGE OCCUR AT THE EXTENSION TUBING. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PROCESS AND RETAINED SAMPLE. AS THE PINCH CLAMP STATE AND THE DAMAGED STATE OF THE EXTENSION TUBING OF THE COMPLAINT SAMPLE CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE EXTENSION TUBING DAMAGE CANNOT BE DETERMINED. H3 OTHER TEXT : SEE NARRATIVE.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, 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 BD INTIMA-II Y 24GAX0.75IN PRN HAD A DEFECTIVE /DAMAGED TUBING THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER; AT 18:00 ON (B)(6) 2023, A CLOSED IV NEEDLE WAS PLACED IN THE PATIENT'S IV, AND THERE WERE NO ABNORMALITIES DURING THE INFUSION, AND THE TUBE WAS SEALED AFTER THE LIQUID WAS FINISHED.AT 08:00 ON SEPTEMBER 10, WHEN THE PATIENT'S IV WAS BEING FLUSHED, IT WAS FOUND THAT THERE WAS LIQUID ESCAPING FROM THE EXTENSION TUBE'S CLIP, AND THE EXTENSION TUBE WAS DAMAGED, AND THE IV NEEDLE WAS REPLACED IMMEDIATELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    744884 BD INTIMA-II Y 24GAX0.75IN PRN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3052734 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown