BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 18415864 · Received December 28, 2023

    Report

    Report Number
    3014704491-2023-00854
    Event Type
    Malfunction
    Date Received
    December 28, 2023
    Date of Event
    October 25, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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#3080092): 1) THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN APRIL 2023, AND PACKAGED AT CFS PACKAGE LINE IN APRIL 2023. WORK ORDER QUANTITY WAS (B)4). 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) REVIEW THE BATCH RECORDS, NO MATERIAL, PROCESS CHANGE. THE STERILIZATION PROCESS IS NORMAL, THE BI STERILITY TEST IS PASSED, AND THE EO RESIDUE TEST IS PASSED, THE PRODUCTS MEET THE REQUIREMENT OF BI STERILITY TEST BEFORE RELEASE, SEE THE ATTACHMENT (B)(4) COC 2. NO ACTUAL SAMPLES AND PHOTOS HAVE BEEN RECEIVED, AND THE DEFECT STATUS CANNOT BE CONFIRMED. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE SEE ATTACHMENT (B)(4) FOR THE TEST REPORT. 4. POSSIBLE CAUSE: 1) THE LARGE PUNCTURE WOUND MAY RESULT IN SEEPAGE, LOCAL REDNESS AND SWELLING. 2) THE MEDICAL DRESSING ISN¿T APPLIED CORRECTLY, WHEN THE PRODUCT MOVES RELATIVE TO INSERTION SITE, WHICH ALSO LEADS TO SEEPAGE, LOCAL REDNESS AND SWELLING. 3) DAMAGE TO THE CATHETER WILL LEAD TO CONTINUOUS LEAKAGE, NOT JUST LOCAL REDNESS AND SWELLING. IF THE CATHETER IS DAMAGED DURING THE PRODUCTION PROCESS, IT CAN BE DETECTED DURING THE EXHAUSTING PROCESS BEFORE THE PUNCTURE. 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. AS THE DEFECTS OF THE COMPLAINED SAMPLE CANNOT BE IDENTIFIED, AND THE USAGE IS UNKNOWN, THE ROOT CAUSE 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 LEAKED THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR 1, LEFT MEDIAL ANKLE FRACTURE 2, LEFT ANKLE SOFT TISSUE INJURY, ON (B)(6) 2023 AT 9:30 A.M. WHEN THE NURSE WAS MEDICALLY ORDERED TO USE A CLOSED IV NEEDLE TO INFUSE FLUIDS (9% SODIUM CHLORIDE INJECTION 100ML + CEFRADINE INJECTION 1.5G), ON (B)(6) 2023 AT 10:10 A.M. THERE WAS A LEAKAGE AT THE NEEDLE CAUSING LOCALIZED REDNESS AND SWELLING IN THE AREA WHERE THE PATIENT WAS USING IT, AND THE INFUSION WAS STOPPED IMMEDIATELY , REPLACED WITH A NEW CLOSED IV INDWELLING NEEDLE. THERE WAS NO FURTHER BLOOD LEAKAGE. THIS DEVICE POSED AN INFECTION RISK TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665793 BD INTIMA-II Y 22GAX1.00IN PRN/EC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3080092

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown