BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 21868598 · Received April 18, 2025

    Report

    Report Number
    3006948883-2025-00081
    Event Type
    Malfunction
    Date Received
    April 18, 2025
    Date of Event
    March 28, 2025
    Report Date
    May 16, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830282
    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#4243811): 1) THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN SEP 2024, AND PACKAGED AT R240 PACKAGE LINE IN SEP 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 4236069, REVIEW THE RAW MATERIAL INSPECTION RECORDS, NO ABNORMALITIES. 2. THE CUSTOMER RETURNED 4 PHOTOS, BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTOS SHOW THAT THE SKU IS 383028, AND THE BATCH CODE IS 4243811, THE SLEEVE STOPPER OF THE PRN IS SEPARATED FROM THE BOTTOM HOUSING. 3. THE RETAINED SAMPLE OF THE COMPLAINT 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), 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. 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 SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. THE PHOTOS SHOW A DEFECT OF THE SLEEVE STOPPER OF THE PRN IS SEPARATED FROM THE BOTTOM HOUSING, AS NO OBVIOUS PRN ASSEMBLY ISSUE CAN BE IDENTIFIED FROM THE PHOTOS, AND NO COMPLAINED SAMPLE IS RECEIVED, THE DEFECT OF THE PRN CANNOT BE ANALYZED, SO THE ROOT CAUSE OF THE COMPLAINT CANNOT BE CONFIRMED. THE PLANT WILL CONTINUE TO TRACK THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM ADAPTER DEFECTIVE/DAMAGED THE CHILD WAS JUST 2 DAYS OLD AND WAS ADMITTED TO OUR NEONATAL WARD WITH A NEONATAL UPPER RESPIRATORY TRACT INFECTION. ON (B)(6) 2025, AT ABOUT 8:30, THE NURSE USED A CLOSED IV NEEDLE TO PERFORM A PUNCTURE, DURING WHICH EVERYTHING WAS FINE. ON (B)(6) 2025, AT 10:09, THE NURSE FOUND THAT THE CHILD HAD FINISHED THE INFUSION, AND THEN THE TUBE WAS CLOSED WITH PHYSIOLOGICAL SALINE. THE TAPE HOLDING THE NEEDLE OF THE HEPARIN CAP WAS REMOVED AND THE RUBBER AT THE FRONT OF THE CAP WAS FOUND TO BE DETACHED, WHICH WAS IMMEDIATELY STERILIZED AND REPLACED WITH A NEW HEPARIN CAP WITH NO ADVERSE EFFECTS ON THE CHILD.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29429 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4243811 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown