BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM

    MDR report key: 20864782 · Received December 6, 2024

    Report

    Report Number
    3002601200-2024-00697
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 7, 2024
    Report Date
    January 20, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830121
    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. THE CUSTOMER RETURNED 4 PHOTOS, BUT DID NOT RETURN ACTUAL SAMPLE. THE PHOTOS SHOW THAT THERE ARE FOREIGN MATTERS ADHERED TO THE SURFACE OF THE CANNULAS. 2. DHR/BHR REVIEW LOT# 3052815. 1- THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2023, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 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. 3. CHECK THE RETAINED SAMPLES OF THIS BATCH, NO FOREIGN MATTER IS FOUND ON THE SURFACE OF THE CANNULAS. 4. ACCORDING TO INTIMA II PRODUCTION PROCESS, THE FOREIGN MATTERS ARE THE PRECIPITATE OF 1502C LUBRICANT - SILICONE. THE CANNULAS OF THE INTIMA II PRODUCTS ARE LUBRICATED WITH 1502C LUBRICANT, FORMING A DENSE LAYER ON THE SURFACE OF THE CANNULA FOR PENETRATION. BD'S MATERIALS LABORATORY IN THE UNITED STATES CONDUCTED A NORMATIVE TEST ON THE SILICONE USED IN THE PRODUCTS, AND THE TEST RESULTS SHOWED THAT THE SILICONE WAS A LUBRICANT FOR MEDICAL PRODUCTS, WHICH MET THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS. 5. AFTER THE CANNULAS ARE LUBRICATED, THE EXCESS SILICONE IS REMOVED BY BLOWING. THE PLANT HAS REQUIRED TO INCREASE THE BLOWING PRESSURE (WITHIN THE PARAMETERS) TO REDUCE THE ADHESION OF SILICONE ON THE SURFACE OF THE CANNULA. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): 1- THERE ARE NO ABNORMALITIES IN THE PRODUCTION PROCESS, NO MATERIAL OR PROCESS CHANGES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS FOR THIS BATCH OF PRODUCTS. 2- THE RETURNED PHOTOS SHOW THAT THERE ARE FOREIGN MATTERS ADHERED TO THE SURFACE OF THE CANNULAS. ACCORDING TO INTIMA II PRODUCTION PROCESS, THE FOREIGN MATTERS ARE THE PRECIPITATE OF 1502C LUBRICANT - SILICONE, A LUBRICANT FOR MEDICAL PRODUCTS, WHICH MEETS THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS, AND THE PLANT HAS REQUIRED TO INCREASE THE BLOWING PRESSURE (WITHIN THE PARAMETERS) TO REDUCE THE ADHESION OF SILICONE ON THE SURFACE OF THE CANNULA.

    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 22GAX1.00IN PRN/EC SLM FOREIGN MATTER ON NOVEMBER 6, WUDING COUNTY PEOPLE'S HOSPITAL V-MART PRODUCTS HAVE BEEN REPORTED TO THE WUDING COUNTY MARKET SUPERVISION AND ADMINISTRATION BUREAU AFTER WHITE SOLIDS WERE OBSERVED DURING USE AFTER NEEDLE WITHDRAWAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119707 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3052815 00382903830121

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown