BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 22GAX1.00IN PRN SLM

    MDR report key: 18294629 · Received December 8, 2023

    Report

    Report Number
    3014704491-2023-00805
    Event Type
    Malfunction
    Date Received
    December 8, 2023
    Date of Event
    November 14, 2023
    Report Date
    February 22, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830145
    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#2110986): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 3 IN (B)(6) 2022, AND PACKAGED AT R240 PACKAGE LINE IN (B)(6) 2022. 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 SAMPLES AND PHOTOS HEVE BEEN RECEIVED. 3. FUNCTIONAL TEST (45PSI LEAKAGE TEST) IS CONDUCTED ON THE RETAINED SAMPLE OF THE COMPLAINED BATCH. THE LEAKAGE TEST IS PASSED, AND NO ABNORMALITY IS FOUND IN THE PRODUCT. PLEASE REFER TO THE ATTACHED TEST REPORT. 4. SKU#383014 IS AN INTIMA II PRODUCT (PVC EXTENSION TUBING). THE INTENDED USE FOR THE BD INTIMA II PRODUCT IS THE INTRAVASCULAR ADMINISTRATION OF FLUIDS. THE FORCING OF LIQUID THROUGH THE PRODUCT DURING ENHANCED CT MAY CAUSE DAMAGE TO THE PRODUCT. 5. THIS PRODUCT HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, AND NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS REGARDING THIS BATCH OF PRODUCTS. AS THE PRODUCT IS NOT SUITABLE FOR HIGH-PRESSURE INJECTION, THE ROOT CAUSE OF THE COMPLAINT DEFECT IS RELATED TO THE INCORRECT USE OF THE PRODUCT. H3 OTHER TEXT : SEE NARRATIVE.

    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 22GAX1.00IN PRN SLM LEAKED WITH POWER INJECTIONTHE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER;(B)(6) 2023 WHEN PLACING AN INDWELLING NEEDLE FOR THE PATIENT, THE NEEDLE WAS INSERTED SMOOTHLY, AND THE NEEDLE CORE WAS WITHDRAWN AND CONNECTED TO THE ACCESSORY CONNECTING TUBE OF THE HIGH-PRESSURE CONTRAST SYRINGE. BEFORE STARTING THE OPERATION, A TEST INJECTION OF 20 ML OF NORMAL SALINE WAS CARRIED OUT SMOOTHLY WITHOUT LEAKAGE. HIGH-PRESSURE SYRINGE A BARREL CONTAINED IODINE THE INJECTION RATE OF ALCOHOL CONTRAST AGENT WAS 2ML/S, AND THE INJECTION RATE OF B-TUBE NORMAL SALINE WAS 1.8ML/S. AT THE BEGINNING OF THE INJECTION, THE PRESSURE WAS OVER 100 MPA AND THEN IMMEDIATELY ROSE TO OVER 300 MPA. AFTER THIS PRESSURE LASTED FOR ABOUT 3 SECONDS, THE INJECTION PRESSURE QUICKLY DROPPED TO OVER 50 MPA AND CONTINUED UNTIL THE SUBSEQUENT INJECTION OF CONTRAST AGENT AND NORMAL SALINE WAS COMPLETED. AFTER THE PATIENT SEPARATED THE CONNECTING TUBE, HE FOUND THAT THE CONTRAST AGENT AND NORMAL SALINE HAD LEAKED ON THE GROUND. HE CHECKED THE INDWELLING NEEDLE CATHETER AND FOUND THAT THE PROXIMAL END OF THE Y-SHAPED CATHETER WAS TORN ABOUT 1CM, AND BLOOD QUICKLY FLOWED OUT FROM THE TEAR IN THE CATHETER. THE CATHETER WAS IMMEDIATELY REMOVED AND THE NEEDLE WAS PRESSED AND INSERTED. AFTER 5 MINUTES, OBSERVE THAT THERE IS NO ABNORMALITY AT THE NEEDLE INSERTION SITE, AND LEAVE AFTER 30 MINUTES OF OBSERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1979960 BD INTIMA-II 22GAX1.00IN PRN SLM INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 2110986 00382903830145

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown