BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19444897 · Received June 2, 2024

    Report

    Report Number
    3002601200-2024-00222
    Event Type
    Malfunction
    Date Received
    June 2, 2024
    Date of Event
    April 24, 2024
    Report Date
    June 20, 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. THE CUSTOMER RETURNED 2 PHOTOS, NO DEFECTIVE SAMPLE. THE PHOTOS CAN BE IDENTIFIED THE SKU OF THE SAMPLE AS 383033. 2. DHR/BHR REVIEW LOT-3108393. 1.THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAY 2023, AND PACKAGED AT R240 PACKAGE LINE IN MAY 2023. 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. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELEVANT FUNCTIONAL TESTS. PLEASE SEE ATTACHMENT FOR TEST REPORTS. 1. LIE DISTANCE IS MEASURED, AND THE RESULT IS WITHIN THE PRODUCT SPECIFICATIONS. 2. PENETRATION FORCE TEST IS PERFORMED, THE NEEDLE TIP FORCE, CATHETER TIP FORCE AND CATHETER DRAG FORCE ALL MEET THE PRODUCT SPECIFICATIONS. 4. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSIONS: ONLY THE SKU OF THE SAMPLE CAN BE CONFIRMED THROUGH THE RETURNED PHOTOS. SINCE NO ABNORMALITIES ARE FOUND IN THE MANUFACTURING PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS, AND NO DEFECTIVE SAMPLE HAS BEEN RECEIVED FOR RELEVANT TESTING, THE ROOT CAUSE OF THE FAILURE TO PUNCTURE CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH A UNILATERAL INGUINAL HERNIA, AND ON (B)(6) 2024, THE CHARGE NURSE FOLLOWED THE DOCTOR'S ORDERS TO TREAT THE PATIENT WITH INTRAVENOUS FLUIDS, AND DURING THE PROCESS, SHE FOUND THAT THE CLOSED IV INDWELLING NEEDLE WAS LEAKING AT THE POINT WHERE THE NEEDLE CONNECTS TO THE BASE, AND SHE WAS UNABLE TO PUNCTURE IT, AND SHE IMMEDIATELY REPLACED IT WITH A DIFFERENT INDWELLING NEEDLE, WHICH DID NOT CAUSE ANY 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
    1884133 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 3108393 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown