BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20304334 · Received September 25, 2024

    Report

    Report Number
    3002601200-2024-00460
    Event Type
    Malfunction
    Date Received
    September 25, 2024
    Date of Event
    August 16, 2024
    Report Date
    September 30, 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

    1. DHR/BHR REVIEW LOT#4061754 1-THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 2 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. 4-THE CANNULA BATCH USED IN THIS BATCH OF PRODUCTS IS 3321469, REVIEW THE INCOMING INSPECTION RESULTS, NO ABNORMALITIES. 2. NO DEFECTIVE SAMPLES AND PHOTOS HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR RELATED FUNCTIONAL TEST: CANNULA RIGIDITY AND TOUGHNESS TEST. THE TEST RESULTS ARE WITHIN THE PRODUCT SPECIFICATIONS. PLEASE REFER TO THE ATTACHMENT FOR TEST REPORTS. 4. ACCORDING TO THE EXPERIENCE OF PREVIOUS MARKET VISITS, IT IS RECOMMENDED THAT: INSERT THE NEEDLE AND CATHETER AT 15°~30° WITH THE BEVEL OF THE NEEDLE TIP UPWARDS, AND AFTER SEEING THE BLOOD RETURN, LOWER THE ANGLE TO 5°~10° TO CONTINUE SEND THE NEEDLE AND CATHETER. 5. 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. AS THE DEFECT STATES OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE SKIN AND VEIN CONDITIONS OF THE PATIENT AND THE PUNCTURE METHOD OF THE NURSE ARE UNKNOWN, THE ROOT CAUSE OF THE DEFORMATION OF THE INDIGNANT NEEDLE AFTER THE PUNCTURE FAILURE 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 RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER WAS DEFECTIVE THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2024 DUE TO FEVER FOR 1 DAY AFTER 6 MONTHS OF ENDOMETRIAL CANCER SURGERY. WEAKNESS, FEELING NAUSEA AND VOMITING, WITH INTERMITTENT FEVER, NEEDING DAILY FLUIDS, THE DOCTOR ORDERED TO GIVE BANDA, VITAMINS, POTASSIUM CHLORIDE NEEDLE INFUSION TREATMENT. 8.16.9:22 AGAIN TO THE RIGHT FOREARM TO LEAVE A SUPERFICIAL INDWELLING NEEDLE INFUSION, A PUNCTURE OF THE VEIN WAS UNSUCCESSFUL, DID NOT RETURN THE NEEDLE, AND PULLING OUT THE NEEDLE TO FIND THAT THE NEEDLE HAS BEEN DEFORMED AND DAMAGED, AND CAN NOT BE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1198108 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4061754 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown