BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 20825163 · Received December 2, 2024

    Report

    Report Number
    3002601200-2024-00676
    Event Type
    Malfunction
    Date Received
    December 2, 2024
    Date of Event
    October 23, 2024
    Report Date
    December 16, 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 CFS 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 ACTUAL SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS CARRIED OUT FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. 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 WERE RECEIVED FROM OTHER HOSPITALS FOR THIS BATCH OF PRODUCTS. SINCE NO ACTUAL SAMPLE IS RETURNED AND THE USE OF THE SAMPLE IS UNKNOWN, THE ROOT CAUSE OF THE LEAKAGE AT THE INSERTION SITE CANNOT BE CONFIRMED.

    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 PATIENT FOR LEFT ULNAR RADIUS FRACTURE AFTER INTERNAL FIXATION SURGERY TO REMOVE THE FRACTURE INTERNAL FIXATION DEVICE ON (B)(6) 2024 AT 10:30 A.M. NURSE ON MEDICAL ADVICE WHEN THE USE OF CLOSED IV INDWELLING NEEDLE INFUSION (5% DEXTROSE INJECTION 250ML + VITAMIN C INJECTION 0.5G), (B)(6) 2024 AT 11:09 A.M. THE NEEDLE AT THE LEAKAGE CAUSED THE PATIENT TO USE THE PLACE OF LOCALIZED REDNESS AND SWELLING, IMMEDIATELY STOP THE INFUSION AND REPLACED WITH A NEW CLOSED IV INDWELLING NEEDLE. THERE WAS NO FURTHER BLOOD LEAKAGE. THIS DEVICE POSES AN INFECTION RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95200 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