BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21129168 · Received January 10, 2025

    Report

    Report Number
    3002601200-2024-00812
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 6, 2024
    Report Date
    February 18, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    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. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS THAT THE SCREW PART OF THE PNR IS DAMAGED OR HAVE DEFICIENCY. 2. DHR/BHR REVIEW LOT#: 4109451. 1. THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT R240 PACKAGE LINE IN MAY 2024. 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. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR APPEARANCE INSPECTION. THE RESULT SHOWS THAT NO ANY DAMAGE OR DEFICIENCY IS FOUND ON THE PRN. 4. ACCORDING TO THE DAMAGE STATE OF THE PRN: THE PRN MAY BE STUCK IN WHICH PART OF THE EQUIPMENT OR BUMPED BY THE GRIPPING JAW WHEN THE EQUIPMENT IS ABNORMAL, OR THIS DEFECT IS FORMING FROM MOLDING. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND IN THE PROCESS AND RETAINED SAMPLE. THE RETURNED PHOTO SHOWS THAT THE SCREW PART OF PRN IS DAMAGED. SINCE NO SUCH SERIOUS DAMAGE HAS BEEN FOUND DURING THE PRODUCTION PROCESS, AND NO COMPLAINTS OF SUCH DEFECTS HAVE BEEN RECEIVED, NO RETURNED SAMPLES FOR FURTHER INVESTIGATION, SO THE ROOT CAUSE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO TRACK AND TREND FOR THIS ISSUE.

    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

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM ADAPTER DEFECTIVE / DAMAGED. ON (B)(6) 2024, PRIOR TO USE, THE DEPARTMENTAL USER NOTED THAT THE CLOSED IV INDWELLING NEEDLE WAS INCOMPLETE, DID NOT SEAL WELL, AND DID NOT MEET CLINICAL USE REGULATIONS. IT WAS FOUND TO BE THE CAUSE OF THE PRODUCT. DISCARD AND REPLACE WITH A NEW CLOSED IV INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498010 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4109451 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown