BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21788494 · Received April 7, 2025

    Report

    Report Number
    3006948883-2025-00056
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 14, 2025
    Report Date
    April 29, 2025
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE CUSTOMER RETURNED 3 PHOTOS AND NO DEFECTIVE SAMPLES. THE PHOTO SHOWS THAT THE COMPLAINED PRODUCT IS A 24GA, Y-TYPE PRODUCT, AND THE LEAKAGE AT THE JUNCTION OF THE EXTENSION TUBE AND THE PP CONNECTOR. DHR/BHR REVIEW (LOT#4233778): THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN AUG 2024 AND PACKAGED AT CFS PACKAGE LINE IN AUG 2024. WORK ORDER QUANTITY WAS (B)(4) EACH. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. PERFORMED 45PSI LEAKAGE TEST FOR THE RETAINED SAMPLES OF THIS BATCH, AND NO COMPLAINT DEFECTS ARE FOUND. DURING THE ASSEMBLY PROCESS OF THE PRODUCT, THE TURNTABLE BREAKAGE, THE JAW WEAR OR THE POOR CENTERING MAY CAUSE DAMAGE TO THE EXTENSION TUBE IN THIS PART. DURING THE USE OF THE PRODUCT, EXTERNAL FORCE WILL ALSO CAUSE DAMAGE TO THIS PART OF THE PRODUCT. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES. SINCE THE DEFECTIVE SAMPLE WAS NOT RECEIVED FOR FURTHER ANALYSIS, THE LEAKAGE STATUS OF THE DEFECTIVE SAMPLE COULD NOT BE RECOGNIZED, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND MONITOR THE DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED AT ADAPTER TUBING JUNCTION AT 11:40 ON (B)(6) 2025, A NURSE IN WARD 12 USED A CLOSED-CELL INTRAVENOUS (IV) NEEDLE TO PLACE AN IV IN A PATIENT IN BED 1211, CHECKED THAT THE OUTER PACKAGING OF THE CLOSED-CELL IV NEEDLE WAS INTACT AND SUCCESSFULLY PUNCTURED, AND FOUND THAT BLOOD LEAKED OUT OF THE EXTENSION TUBE OF THE CLOSED-CELL IV NEEDLE AND THE Y-TYPE CONNECTOR WHEN SHE WAS READY TO DRAW VENOUS BLOOD, SO SHE IMMEDIATELY PULLED OUT THE CLOSED-CELL IV NEEDLE, PACIFIED THE PATIENT'S EMOTIONS, AND REPLACED IT WITH A NEW ONE OF THE SAME ORIGIN AND THE SAME BATCH NUMBER AND THE SAME MODEL. HE IMMEDIATELY PULLED OUT THE CLOSED IV NEEDLE, CALMED THE PATIENT'S EMOTION, AND REPLACED IT WITH A NEW CLOSED IV NEEDLE OF THE SAME ORIGIN AND THE SAME BATCH NUMBER AND THE SAME MODEL, WHICH CAUSED SECONDARY INJURY TO THE PATIENT. IN THE FOLLOW-UP OPERATION, THE SAME BATCH OF PRODUCTS, DID NOT FIND SIMILAR PROBLEMS. BECAUSE THE CLOSED IV NEEDLE HAS BEEN CONTAMINATED BY THE PATIENT'S BLOOD, LEAVE THE VIDEO PICTURE TO BE DISCARDED AFTER PROCESSING.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605406 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 4233778

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown