BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM

    MDR report key: 18651637 · Received February 6, 2024

    Report

    Report Number
    3002601200-2024-00017
    Event Type
    Malfunction
    Date Received
    February 6, 2024
    Date of Event
    January 12, 2024
    Report Date
    March 15, 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

    1. DHR/BHR REVIEW (LOT#: 3250445): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN SEPTEMBER 2023, AND PACKAGED AT CFS PACKAGE LINE IN SEPTEMBER 2023. 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 ACTUAL SAMPLES AND PICTURES HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLES OF THIS BATCH ARE TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETERS. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. SKU#: 383012 IS AN INTIMA II PRODUCT (PVC EXTENSION TUBING). THE INTENDED USE FOR THE BD INTIMA II PRODUCT IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THIS PRODUCT HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 5. DAMAGE TO THE CATHETER CAUSED DURING ASSEMBLY CAN BE DETECTED DURING THE EXHAUSTING PROCESS PRIOR TO PUNCTURE. 6. COMMON CAUSES OF FLUID LEAKAGE AND BLOOD LEAKAGE AT THE INSERTION SITE: 1) THE PUNCTURE ANGLE IS SO SMALL THAT THE PUNCTURE WOUND IS RELATIVELY BIG. IT IS RECOMMENDED THAT THE NURSE SHOULD HAND THE PRODUCT WITH BEVEL OF NEEDLE TIP UPWARD AND PUNCTURE IN 15°~30° AT INSERTION SITE, PRESS THE NEEDLE DOWN IN 5°~10° TO INSERT AFTER SEEING BLOOD RETURN. 2) THE MEDICAL DRESSING ISN'T APPLIED CORRECTLY, WHICH LEAD TO LEAKAGE WHEN THE PRODUCT MOVES RELATIVE TO INSERTION SITE. IT IS RECOMMENDED THAT THE NURSE SHOULD HAND THE MEDICAL DRESSING WITHOUT TENSION, PLACE IT CORRECTLY, PINCH THE CATHETER HUB TO ENSURE FULLY FIXED BY THE MEDICAL DRESSING AND THEN PASTE TO THE PERIPHERY. 7. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN PROCESS AND RETAINED SAMPLES, THE PRODUCT HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, NO DEFECTIVE SAMPLES ARE RECEIVED, AND NO SIMILAR COMPLAINTS FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, IT CANNOT BE CONFIRMED THAT THE COMPLAINED DEFECTS ARE RELATED TO PRODUCT QUALITY.

    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 20GAX1.16IN PRN SLM LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: REPORT THE EXTRAVASATION OF FLUID AND BLOOD AT THE PUNCTURE POINT OF THE ELBOW JOINT WHEN THIS PRODUCT WAS USED FOR ANGIOGRAPHY ON TWO PATIENTS; SAMPLES THAT ARE CONTAMINATED CANNOT BE RETURNED, AND PHOTOS ARE PROVIDED; GREEN CLAIMS ARE REQUIRED, AND A COMPLAINT RESPONSE LETTER AND ACCEPTANCE LETTER ARE REQUIRED; THE NUMBER OF AFFECTED UNITS IN THE EMERGENCY ROOM (2 UNITS) AND THE NUMBER OF AFFECTED UNITS IN THE CT ROOM (5 UNITS), A TOTAL OF 7 UNITS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955932 BD INTIMA-II 20GAX1.16IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3250445 00382903830077

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown