BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 24GAX0.75IN PRN SLM

    MDR report key: 20077276 · Received August 27, 2024

    Report

    Report Number
    3002601200-2024-00409
    Event Type
    Malfunction
    Date Received
    August 27, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 27, 2024
    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

    1. FROM THE FOLLOW-UP INFORMATION, IT IS LEARNED THAT THERE ARE NO OTHER CHANGES EXCEPT THE PRN FALLING OFF FROM THE INDWELLING NEEDLE. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 2. DHR/BHR REVIEW LOT#4052031 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 IN (B)(6) 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN (B)(6) 2024. WORK ORDER QUANTITY WAS (B)(4). 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. 3. THE RETAINED SAMPLE OF THE COMPLAINED BATCH IS TAKEN FOR PRN TORQUE TEST, AND THE TEST RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. IN THE ASSEMBLY PROCESS OF PRN, THERE ARE TORQUE AND ASSEMBLY STROKE MONITORING TO ENSURE THAT THE LUER OF PRN CAN BE ASSEMBLED INTO THE PP CONNECTOR TO A CERTAIN DEPTH AND THE THREAD HAS A GOOD FASTENING EFFECT. IF THE PRN IS NOT IN PLACE, THE EQUIPMENT WILL ALARM AND REMOVE THE PRODUCT. HOWEVER, ALTHOUGH PRN IS FASTENED TO THE PRODUCT DURING ASSEMBLY, IT MAY COME LOOSE IF IT IS VIBRATED DURING TRANSPORTATION. THEREFORE, THE IFU OF THE PRODUCT INDICATES THAT THE PRN SHOULD BE TIGHTENED BEFORE USE TO PREVENT LEAKAGE. 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. SINCE NO DEFECTIVE SAMPLE IS RECEIVED FOR RELEVANT TESTING AND THE USAGE OF THIS SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE PRN FALLING OFF WHEN SEALING THE TUBE CANNOT BE DETERMINED.

    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 INFORMAITON AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II 24GAX0.75IN PRN SLM END CAP WAS LOOSE WHEN SEALING THE TUBE, IT WAS FOUND THAT THE LEATHER PLUG FELL OFF THE INTERFACE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30175 BD INTIMA-II 24GAX0.75IN PRN SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052031 00382903830282

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown