BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN

    MDR report key: 18027257 · Received October 29, 2023

    Report

    Report Number
    3014704491-2023-00677
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    August 5, 2023
    Report Date
    December 14, 2023
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903832842
    PMA / PMN Number
    K200891
    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. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. THE CUSTOMER RETURNED 1 PHOTO, NO DEFECTIVE SAMPLE. THE PHOTO SHOWS : THERE ARE SOME HOLES IN THE MIDDLE OF THE EXTENSION TUBING, THERE IS LIQUID IN THE EXTENSION TUBING, THERE SEEMS TO BE SIGNS OF SCALDING AND SHRINKING NEAR THE HOLES, AND THERE IS NO SIGN OF CLAMPING OF THE PINCH CLAMP. 2. DHR/BHR REVIEW(LOT#3108239): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2023, AND PACKAGED AT R245 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. 4)THE EXTENSION TUBING BATCH USED IN THIS BATCH OF PRODUCTS IS 3083109, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 3. THE RETAINED SAMPLES OF THIS BATCH ARE INSPECTED, AND THERE IS NO DAMAGE TO THE UNIT PACKAGING, POOR SEAL OF THE UNIT PACKAGING, OR HOLES IN THE EXTENSION TUBING. PLEASE SEE ATTACHMENT PR# 9068911-1 FOR THE INSPECTION REPORT. 4. DURING THE PACKAGING PROCESS, DUE TO THE MANUAL PLACEMENT OF THE PRODUCT IS NOT IN PLACE AND THE ABNORMAL VIBRATION OF THE EQUIPMENT, THE EXTENSION TUBING WILL BE PRESSED INTO THE SEAL OF THE PACKAGING, RESULTING IN THE POOR SEAL OF THE PACKAGING, AND THE EXTENSION TUBING WILL BE FLATTENED (PARTIALLY CUT OFF), WHICH WILL NOT CAUSE THE EXTENSION TUBING TO HAVE HOLES, AS SHOWN IN ANNEX (B)(4). 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): THE RETURNED PHOTO SHOWS THAT THERE ARE SOME HOLES IN THE MIDDLE OF THE EXTENSION TUBING. DUE TO NO ABNORMALITIES IN THE PROCESS AND RETAINED SAMPLES, NO SIMILAR COMPLAINTS FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, AND NO CLEARER IDENTIFICATION OF DEFECTS IN THE COMPLAINED SAMPLE, THE ROOT CAUSE OF THE POOR PACKAGING AND HOLES IN THE EXTENSION TUBING CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO FOLLOW UP ON THE COMPLAINT AND FOCUS ON SUCH DEFECTS.

    Description of Event or Problem · 0

    IT WAS REPORTED BD INTIMA-II Y 24GAX0.75IN PACKAGE WAS DAMAGED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DUE TO THE REPLACEMENT OF THE PACEMAKER, THE PATIENT USED A CLOSED INTRAVENOUS INDWELLING NEEDLE FOR INTRAVENOUS INFUSION ON (B)(6) 2023, AND FOUND THAT THE PACKAGING WAS NOT TIGHT AND THE PIPELINE WAS DAMAGED, SO HE PROMPTLY REPLACED IT WITH A NEW CLOSED INDWELLING NEEDLE. NO HARM WAS CAUSED TO THE PATIENT, AND THE ADVERSE EVENT WAS LATER REPORTED TO THE EQUIPMENT DEPARTMENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMAITON PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130459 BD INTIMA-II Y 24GAX0.75IN INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3108239 00382903832842

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown