BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 22GAX1.00IN PRN EC SLM

    MDR report key: 20067028 · Received August 26, 2024

    Report

    Report Number
    3002601200-2024-00408
    Event Type
    Malfunction
    Date Received
    August 26, 2024
    Date of Event
    July 17, 2024
    Report Date
    August 28, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830695
    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

    DHR/BHR REVIEW LOT#4052036. THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN APRIL 2024. WORK ORDER QUANTITY WAS (B)(4) EA. REVIEW THE IN-PROCESS TEST REPORTS AND OUTGOING TEST REPORTS, AND ALL TEST RESULTS MEET THE PRODUCT SPECIFICATIONS. REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 45PSI LEAKAGE TEST IS CARRIED OUT ON THE RETAINED SAMPLE OF THIS BATCH, AND NO LEAKAGE IS FOUND. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): SINCE NO ABNORMALITIES ARE FOUND IN THE PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, THE SPECIFIC SITE AND ABNORMAL STATE OF THE LEAKAGE OF THE INDWELLING NEEDLE CANNOT BE IDENTIFIED, SO THE ROOT CAUSE CANNOT BE DETERMINED. THE PLANT WILL CONTINUE TO FOLLOW UP THE COMPLAINT.

    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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN EC SLM NPVC LEAKED. THE PATIENT IS A PATIENT WITH CEREBRAL HEMORRHAGE. THE INTRAVENOUS DRUG SOLUTION NEEDS TO BE INFUSED THROUGH AN INDWELLING NEEDLE. AFTER THE PATIENT HAS SUCCESSFULLY PUNCTURED, THE DRUG SOLUTION IS CONNECTED. IT IS FOUND THAT THE DRUG IS LEAKING AT THE INTERFACE OF THE INDWELLING NEEDLE. THE CONNECTION PORT HAS BEEN TIGHTENED AND THE DRUG SOLUTION IS STILL LEAKING. GIVE THE PATIENT QUICKLY REMOVE THE INDWELLING NEEDLE, REPLACE THE INDWELLING NEEDLE AND REINSERT IT, COMFORT AND EXPLAIN TO THE PATIENT AND FAMILY MEMBERS, AND OBTAIN THE UNDERSTANDING AND COOPERATION OF THE FAMILY MEMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    278921 BD INTIMA-II Y 22GAX1.00IN PRN EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052036 00382903830695

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown