BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20283392 · Received September 23, 2024

    Report

    Report Number
    3002601200-2024-00455
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 30, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830190
    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#4052033 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN MARCH 2024, AND PACKAGED AT R240 PACKAGE LINE IN MARCH 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. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTING: 45PSI LEAKAGE TEST. THE TEST IS PASSED, NO LEAKAGE IS FOUND ON THE SAMPLE. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. 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 REGARDING THIS BATCH OF PRODUCTS. BECAUSE THE DEFECTIVE SAMPLE IS NOT RETURNED, THE LUER STATUS OF THE PRN AND THE PP CONNECTOR CANNOT BE CONFIRMED, SO THE ROOT CAUSE OF LEAKAGE 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 INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM LEAKED. 37 BEDS, HOSPITALIZATION NUMBER: (B)(6), DIAGNOSIS: BILATERAL OVARIAN CYSTS, TODAY THE SEVENTH DAY AFTER LAPAROSCOPY, THE LONG PRESCRIPTION LEVOFLOXACIN INJECTION STATIC ANTI-INFLAMMATORY TREATMENT, TO PLACE AN INDWELLING NEEDLE SUCCESSFULLY, OPEN THE INFUSION REGULATOR TO ADJUST THE DRIP RATE, THE OTHER END OF THE INDWELLING NEEDLE HEPARIN CAP SEEPAGE, RE-TIGHTENING OF THE INFUSION DEVICE AND THE INDWELLING NEEDLE CONNECTION, WHEN YOU OPEN THE INFUSION THERE IS STILL A SMALL AMOUNT OF SEEPAGE, TO RULE OUT THE FAILURE OF THE INFUSION DEVICE, CONSIDERING THE NEEDLE WAS BROKEN, AND THE NEEDLE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489054 BD INTIMA-II Y 22GAX1.00IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052033 00382903830190

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown