BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20507533 · Received October 22, 2024

    Report

    Report Number
    3002601200-2024-00541
    Event Type
    Malfunction
    Date Received
    October 22, 2024
    Date of Event
    September 17, 2024
    Report Date
    October 24, 2024
    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# 4052073. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 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. 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. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITIES ARE FOUND IN THE 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, RELEVANT TESTS CANNOT BE CARRIED OUT, AND THE ROOT CAUSE OF THE LEAKAGE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED AT CATHETER JUNCTION THE PATIENT WAS GIVEN AN INDWELLING NEEDLE ON (B)(6) 2024, AND THE NEXT DAY (B)(6) WHEN HE WENT FOR A FLUID INFUSION, HE FOUND THAT THERE WAS A SALINE LEAKAGE FROM THE INDWELLING NEEDLE, BECAUSE THERE WAS BLOOD RETURN WHEN THE TUBE WAS FLUSHED AND PUMPED BACK, INDICATING THAT IN THE INDWELLING NEEDLE WAS IN THE BLOOD VESSEL, AND THE INFUSION OF THE FLUID DID NOT TAKE LONG BEFORE THERE WAS A FLUID LEAKAGE, AND IT WAS SUSPECTED THAT THERE WAS DAMAGE TO THE NEEDLE, AND THE NEEDLE WAS IMMEDIATELY REMOVED AND THE TUBE WAS REINTRODUCED WITHOUT ANY APPARENT HARM TO THE PATIENT.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344375 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052073 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown