BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18792495 · Received February 27, 2024

    Report

    Report Number
    3002601200-2024-00058
    Event Type
    Malfunction
    Date Received
    February 27, 2024
    Date of Event
    January 18, 2024
    Report Date
    March 20, 2024
    Manufacturer
    BD SUZHOU (MDS)
    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. THE CUSTOMER RETURNED 2 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SAMPLE HAS NO PINCH CLAMP, THE SKU IS 383033, AND THE BATCH CODE IS 3080069. 2. DHR/BHR REVIEW (LOT#: 3080069): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2023, AND PACKAGED AT R240 PACKAGE LINE IN MAY 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, AND NO SAMPLE WITHOUT PINCH CLAMP IS FOUND. PLEASE SEE ATTACHMENT FOR THE INSPECTION REPORT. 4. IN INTIMA II AUTO LINE 2 ZONE 7, THERE ARE VISUAL SYSTEMS FOR 100% DETECTION OF THE ASSEMBLY OF THE PINCH CLAMP, THE VISUAL SYSTEMS ARE STABLE AND EFFECTIVE, EVERY DAY AT 7:00, 19:00 AND WHEN CHANGING GAUGE, STANDARD SAMPLES WILL BE USED TO CHALLENGE THE VISUAL SYSTEMS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTOS SHOW THAT THE SAMPLE HAS NO PINCH CLAMP. SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLES, AND FROM THE ANALYSIS OF THE PRODUCT PROCESS, THERE ARE VISUAL SYSTEMS FOR 100% DETECTION OF THE ASSEMBLY OF THE PINCH CLAMP, THE ROOT CAUSE OF THE PINCH CLAMP MISSING CANNOT BE DETERMINED. THIS COMPLAINT IS AN ISOLATED CASE AND THE PLANT WILL CONTINUE TO TRACK AND MONITOR THE DEFECT.

    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 THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM WAS MISSING A COMPONENT, THE TUBING CLAMP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A FEMUR FRACTURE, AND ON (B)(6) 2024, THE CHARGE NURSE FOLLOWED THE DOCTOR'S ORDERS FOR INTRAVENOUS FLUID THERAPY FOR THE PATIENT, AND WHEN PREPARING TO PERFORM VENIPUNCTURE, SHE FOUND THAT THE CLOSED IV INDWELLING NEEDLE LACKED A SEALING CLIP AND WAS UNUSABLE, AND SHE IMMEDIATELY REPLACED IT WITH ANOTHER INDWELLING NEEDLE WITHOUT CAUSING HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116402 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3080069 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown