BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23523727 · Received November 11, 2025

    Report

    Report Number
    3006948883-2025-00853
    Event Type
    Malfunction
    Date Received
    November 11, 2025
    Date of Event
    October 31, 2025
    Report Date
    January 19, 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

    1. DHR/BHR REVIEW (LOT#3052848): 1)THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APR 2023 AND PACKAGED AT CFS PACKAGE LINE IN APR 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. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3)REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 4)THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS ARE 3083083 AND 3083084, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED ONE PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE UNIT PACKAGE WAS UNOPENED, BATCH NUMBER 3052848. THE SAMPLE¿S PRN LATEX PLUG WAS YELLOWED AND DAMAGED, AND THERE WAS A BLACK FOREIGN PARTICLE ON THE SHIELD. 3. CHECK THE RETAINED SAMPLES FROM THIS BATCH: NO YELLOWING OR DAMAGE WAS FOUND ON THE HEPARIN CAPS. AN APPEARANCE INSPECTION WAS ALSO PERFORMED ON THE RETAINED SAMPLES, AND NO ABNORMALITIES IN THE HEPARIN CAPS OR FOREIGN MATTER IN THE SHIELD WERE FOUND. 4. THE ABNORMALITY OF THE HEPARIN CAP SHOWN IN THE PHOTO MAY BE CAUSED BY AGING OF THE LATEX PLUG IN THE HEPARIN CAP. FACTORS SUCH AS HIGH TEMPERATURE, STRONG LIGHT, HUMIDITY, AND OXIDATION (INCLUDING THERMAL OXIDATION AGING, PHOTO-OXIDATION AGING, AND OZONE AGING) CAN ALL LEAD TO AGING OF THE LATEX PLUG. THE FACTORY DOES NOT HAVE CONDITIONS DURING THE PRODUCTION PROCESS THAT COULD CAUSE THIS DEFECT. 5. THE FOREIGN MATTER ON THE SHIELD MAY BE SCORCH MARKS GENERATED DURING THE SHIELD MANUFACTURING PROCESS, OR IT COULD HAVE OCCURRED IF THE PRODUCT WAS STUCK AT A CERTAIN POSITION DURING AN ABNORMAL SITUATION IN PRODUCTION. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN PROCESS AND RETAINED SAMPLES, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS ABNORMALITIES ON THE HEPARIN CAP AND FOREIGN MATTER ON THE SHIELD. HOWEVER, SINCE THE DEFECTIVE SAMPLES WERE NOT RECEIVED FOR FURTHER TESTING AND ANALYSIS, AND THIS COMPLAINT IS AN ISOLATED CASE, IT IS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE OR SPECIFIC SOURCE OF THE DEFECT. THE FACTORY WILL CONTINUE TO MONITOR THE OCCURRENCE OF SUCH DEFECTS.

    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 AVAILABLE.

    Description of Event or Problem · 0

    THE PATIENT WAS ADMITTED AT 17:14 ON (B)(6) 2025, WITH ACUTE OTITIS MEDIA (RIGHT EAR) DUE TO RIGHT EAR PAIN LASTING ONE DAY. AFTER COMPLETING EXAMINATIONS, AT 01:50 ON (B)(6) 2025, THE PATIENT REPORTED RIGHT EAR PAIN ACCOMPANIED BY FEVER. TEMPERATURE MEASURED AT 38.3°C. THE PATIENT INFORMED THE PHYSICIAN AND RECEIVED ANTI-INFLAMMATORY AND HORMONAL MEDICATIONS AS PRESCRIBED. DUE TO THE PATIENT'S CONDITION REQUIRING A CLOSED-SYSTEM INTRAVENOUS CATHETER, AT 01:58 THE NURSE INSPECTED THE CATHETER AND DISCOVERED: ALTHOUGH THE CLOSED-SYSTEM INTRAVENOUS CATHETER WAS WITHIN ITS EXPIRATION DATE AND UNOPENED, THE HEPARIN CAP INSIDE THE PACKAGING EXHIBITED SIGNIFICANT ABNORMALITIES: THE TIP EXHIBITED YELLOWING, DAMAGE, AND AN INCOMPLETE STATE. ADDITIONALLY, A BLACK FOREIGN SUBSTANCE WAS VISIBLE ADHERING TO THE LUMEN AREA INSIDE THE TRANSPARENT TUBING OF THE IV CATHETER. UPON DISCOVERY, THE NURSE REPLACED THE IV CATHETER WITH A NEW ONE AT 02:00, AND THE PROCEDURE PROCEEDED SMOOTHLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581081 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON 3052848

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown