BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23572377 · Received November 17, 2025

    Report

    Report Number
    3006948883-2025-00872
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 9, 2025
    Report Date
    February 1, 2026
    Manufacturer
    BECTON DICKINSON
    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

    1. DHR/BHR REVIEW(LOT#5076368): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MAR, 2025, AND PACKAGED AT R240 & CFS PACKAGE LINE IN MAR, 2025. 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 BATCHES USED IN THIS BATCH OF PRODUCTS IS 5010813, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. 3 PHOTOS WERE PROVIDED FOR THIS COMPLAINT, BUT THERE WAS NO ACTUAL SAMPLE PROVIDED. THE PHOTOS SHOW THAT THE EXTENSION TUBING IS SEPARATED FROM THE PP CONNECTOR, PP CONNECTOR NOT FOUND. THE EXTENSION TUBING HAS NO OBVIOUS DEFORMATION, AND THE FRACTURE SURFACE OF THE EXTENSION TUBING SEEMS TO BE FLAT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN TO TEST THE PULL STRENGTH BETWEEN THE EXTENSION TUBING AND THE PP CONNECTOR AND 45PSI LEAKAGE TEST, AND THE TEST RESULTS ARE ALL WITHIN THE PRODUCT SPECIFICATIONS. 4. ANALYSIS OF POSSIBLE CAUSES: 1)NO LEAKAGE OCCURRED IN THE PROCESS OF EXHAUST, PUNCTURE, INFUSION, FLUSHING AND SEALING, INDICATING THAT THE EXTENSION TUBING WAS NOT DAMAGED IN THE PRODUCTION PROCESS. 2)NO OBVIOUS DEFORMATION IS FOUND IN THE EXTENSION TUBING, INDICATING THAT THE EXTENSION TUBE WAS NOT BROKEN BY PULL OF EXTERNAL FORCE. 3)THE FRACTURE SURFACE OF THE EXTENSION TUBING SEEMS TO BE FLAT, WHICH INDICATES THAT THE EXTENSION TUBING MAY BE FRACTURED BY SHARP INSTRUMENTS. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE GENERAL STATE OF THE FRACTURE OF THE EXTENSION TUBING IS IDENTIFIED THROUGH THE RETURNED PHOTO. AS NO DEFECTIVE SAMPLE IS RECEIVED, FURTHER INSPECTION AND ANALYSIS CANNOT BE CARRIED OUT, SO THE ROOT CAUSE OF THE FRACTURE OF THE EXTENSION TUBING CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    Description of Event or Problem · 0

    ON (B)(6) 2025, DURING PATIENT TRANSFER FOLLOWING IV CATHETER PLACEMENT, THE CONNECTOR AT THE END OF THE CATHETER DISCONNECTED FROM THE EXTENSION TUBE. THE PATIENT SUSTAINED NO INJURY. A NEW IV CATHETER WAS REPLACED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289573 INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 5076368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown