BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21538861 · Received March 6, 2025

    Report

    Report Number
    3002601200-2025-00099
    Event Type
    Malfunction
    Date Received
    March 6, 2025
    Date of Event
    January 21, 2025
    Report Date
    April 16, 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

    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#4109454): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAY 2024, AND PACKAGED AT R240&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 4113254, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 1 PHOTO, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE PRODUCT SPECIFICATION IS 24GA, SLEEVE STOPPER OF THE PRN IS SEPARATED FROM THE BOTTOM HOUSING. 3. THE RETAINED SAMPLE OF THE COMPLAINT BATCH IS TAKEN FOR THE PRN PULL FORCE TEST (I.E., TEST THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING), AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 4. THE POSSIBLE FACTORS AFFECTING THE SEPARATION FORCE BETWEEN THE SLEEVE STOPPER AND THE BOTTOM HOUSING: RAW MATERIAL FACTORS (INCLUDING THE TENSION OF THE SLEEVE STOPPER, THE DEGREE OF SHRINKAGE OF THE SHRINK BAND), THE ASSEMBLY OF THE PRN, THE FLOW RATE AND PRESSURE DURING THE USE OF THE INDWELLING NEEDLE. CONCLUSION(S): THE PHOTO SHOWS A DEFECT OF THE SLEEVE STOPPER OF THE PRN IS SEPARATED FROM THE BOTTOM HOUSING. THE ROOT CAUSE OF THIS DEFECT CANNOT BE DETERMINED AS NO OBVIOUS PRN ASSEMBLY ISSUE CAN BE IDENTIFIED FROM THE PHOTOS, NO ABNORMALITY IS FOUND IN THE RELEVANT TEST OF THE RETAINED SAMPLE, AND NO DEFECTIVE SAMPLE IS RECEIVED FOR FURTHER TEST. AND THE PLANT WILL CONTINUE TO TRACK THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM ADAPATER WAS DEFECTIVE/DAMAGED TUBE FLUSHING MANEUVER PRIOR TO INTRAVENOUS NUTRITION, DISLODGEMENT DURING SALINE PUSH, NEEDLE TIP DISLODGED AND EXPOSED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    828041 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4109454 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown