BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 21832744 · Received April 14, 2025

    Report

    Report Number
    3006948883-2025-00070
    Event Type
    Malfunction
    Date Received
    April 14, 2025
    Date of Event
    March 26, 2025
    Report Date
    May 6, 2025
    Manufacturer
    BD SUZHOU (MDS)
    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#4109456): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN MAY 2024, AND PACKAGED AT CFS 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. 4) THE PRN BATCHES USED IN THIS BATCH OF PRODUCTS IS 4113255, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 1 PHOTO AND 1 SAMPLE. THE SAMPLE WAS THE BASE OF THE PRN, AND ITS LATEX STOPPER AND SHRINK FILM WERE NOT FOUND. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST AND THE PRN PULL FORCE TEST (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING), THE TESTS RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 4. POSSIBLE CAUSES: RAW MATERIAL FACTORS (INCLUDING THE TENSION OF THE SLEEVE STOPPER, THE DEGREE OF SHRINKAGE OF THE SHRINK BAND), THE ASSEMBLY OF THE PRN (THE SHRINK BAND FEEDING STATION IS NOT ALIGNED OR THE RAW MATERIALS INCLUDING SLEEVE STOPPER AND SHRINK BAND ARE ABNORMAL, RESULTING IN THE SHRINK BAND IS NOT ASSEMBLED IN PLACE.), THE FLOW RATE AND PRESSURE DURING THE USE OF THE INDWELLING NEEDLE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. ONLY THE BASE OF THE PRN WAS RETURNED, AND THE TYPE OF SHRINK FILM AND THE ASSEMBLY STATUS OF THE PRN COULD NOT BE DETERMINED. THIS IS THE FIRST COMPLAINT ABOUT THE PULL FORCE OF THE PRN IN THIS BATCH, AND THE PLANT WILL CONTINUE TO TRACK 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 IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM ADAPTER / CONNECTOR DEFECTIVE / DAMAGED TODAY, I RECEIVED A COMPLAINT, ITEM NUMBER: 383028, BATCH NUMBER: 4109456. THE PEDIATRIC INFUSION ROOM OF YUYAO PEOPLE'S HOSPITAL GAVE THE CHILD CATHETER INFUSION ON MARCH 25, AND THE PATIENT WENT TO THE HOSPITAL FOR A SECOND INFUSION ON MARCH 26, AND THE NURSE FOUND THAT THE RUBBER PLUG OF THE INDWELLING NEEDLE FELL OFF AND RE-INSERTED THE INFUSION. THE FAMILY DENIED ANY DAMAGE TO THE HOME. SAMPLES CAN BE RETURNED TO THE FACTORY THIS WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270085 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4109456

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown