BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20292483 · Received September 24, 2024

    Report

    Report Number
    3002601200-2024-00457
    Event Type
    Malfunction
    Date Received
    September 24, 2024
    Date of Event
    August 15, 2024
    Report Date
    October 14, 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 RETURNS 1 PHOTO BUT DID NOT RETURN THE DEFECTIVE SAMPLE. THE PHOTO SHOWS SWELLING AT THE PATIENT'S INSERTION SITE. 2. DHR/BHR REVIEW LOT#4061754. 1-THE PRODUCTS OF THIS BATCH 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. AMONG THEM, THE PRN TORQUES MEET THE OUTGOING INSPECTION REQUIREMENT. 3-REVIEW THE PRODUCTION RECORDS WITH NO NONCONFORMANCE, DEVIATION OR REWORK ACTIVITIES. 3. THE RETAINED SAMPLE OF THIS BATCH IS CARRIED OUT FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE SEE ATTACHMENT FOR THE TEST REPORT. 4. THE CAUSES OF LEAKAGE AT THE INSERTION SITE ARE COMPLEX, AND THE COMMON CAUSES ARE AS FOLLOWS: 1) THE PUNCTURE ANGLE IS SO SMALL THAT THE PUNCTURE WOUND IS RELATIVELY BIG. 2) THE MEDICAL DRESSING IS NOT APPLIED CORRECTLY, WHICH LEAD TO LEAK WHEN THE PRODUCT MOVES RELATIVE TO INSERTION SITE. 5. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT 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 ABOUT THIS BATCH OF PRODUCTS. THE RETURNED PHOTO SHOWS SWELLING AT THE PATIENT'S INSERTION SITE. SINCE THE DEFECTIVE SAMPLE HAS NOT BEEN RETURNED AND THE USAGE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE LEAKAGE AND SWELLING AT THE INSERTION SITE CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM LEAKED. THE PATIENT WAS DIAGNOSED WITH APPENDICEAL MUCINOUS TUMOR FOR 8 MONTHS AND CONSTIPATION FOR 6 MONTHS WAS ADMITTED ON 2024.8.1 FOR FURTHER TREATMENT. ADVANCED AGE, PHYSICAL WEAKNESS, ACCOMPANIED BY CONSTIPATION, NAUSEA, ABDOMINAL DISTENSION IS OBVIOUS.8.2 PLACED IN THE ABDOMINAL DRAINAGE TUBE 1 DAILY DRAINAGE OF ASCITES, THE NEED FOR DAILY INFUSION, THE MEDICAL ADVICE TO PANTOPRAZOLE, CONRAD, VITAMIN INJECTION INFUSION QD TREATMENT.8.13.9:15 AGAIN TO THE RIGHT FOREARM INDWELLING SUPERFICIAL INDWELLING NEEDLE INFUSION, THE END OF THE INFUSION IS NORMAL SEALING THE TUBE.8.15.10:50 FOUND THAT THE NEEDLE OOZING SWELLING IS OBVIOUS, ACCOMPANIED BY PAIN AND COULD NOT BE USED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2104158 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