BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 20GAX1.16IN PRN SLM NPVC

    MDR report key: 18446071 · Received January 4, 2024

    Report

    Report Number
    3014704491-2023-00875
    Event Type
    Malfunction
    Date Received
    January 4, 2024
    Date of Event
    December 1, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BD (SUZHOU)
    Product Code
    FOZ
    UDI-DI
    00382903830572
    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. THE CUSTOMER RETURNED 1 PHOTO AND 1 DEFECTIVE SAMPLE. THE SEPTUM OF THE SAMPLE HAD BEEN DISPLACED. 1)CHECK THE DISTRIBUTION OF UV ADHESIVE AT THE CATHETER HUB UNDER THE PURPLE LAMP. NO ABNORMALITY IS FOUND. PLEASE SEE ATTACHMENT PR#(B)(4) FOR THE PHOTOS. 2. THE SEPTUM AND THE CATHETER HUB ARE BONDED BY UV ADHESIVE. AFTER THE ADHESIVE IS DRIED, THE VISUAL INSPECTION SYSTEM CONDUCTS 100% INSPECTION, WHICH WILL AUTOMATICALLY IDENTIFY AND REMOVE DEFECTIVE PRODUCTS. THE VISUAL INSPECTION SYSTEM IS CHALLENGED WITH STANDARD SAMPLES EVERY DAY AT 7:00, 19:00 AND WHEN CHANGING PRODUCT GAUGE TO ENSURE THE EFFECTIVENESS OF THE INSPECTION. 3. DHR/BHR REVIEW(LOT#3234067): 1)THIS BATCH OF PRODUCTS WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN SEPTEMBER 2023, AND PACKAGED AT R240 PACKAGE LINE IN SEPTEMBER 2023. 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. FUNCTIONAL TEST (45PSI LEAKAGE TEST) IS CONDUCTED ON THE RETAINED SAMPLE OF THE COMPLAINED BATCH, NO LEAKAGE IS FOUND, AND NO ABNORMALITY IS FOUND ON THE SEPTUM. PLEASE SEE ATTACHMENT PR#(B)(4) FOR THE TEST REPORT. 5. THIS PRODUCT (SKU 383057) HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION. 6. NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS. CONCLUSION(S): NO ABNORMALITY IS FOUND ON PROCESS AND RETAINED SAMPLE, NO SIMILAR COMPLAINTS HAVE BEEN RECEIVED FROM OTHER HOSPITALS ABOUT THIS BATCH OF PRODUCTS, AND THE SEPTUM OF THE RETURNED SAMPLE IS DISPLACED. BECAUSE THE DISTRIBUTION OF UV ADHESIVE AT THE CATHETER HUB IS NOT ABNORMAL, AND THE PRODUCT HAS NEVER BEEN DECLARED TO BE USED FOR HIGH-PRESSURE INJECTION, SO THE ROOT CAUSE OF THE DISPLACEMENT OF THE SEPTUM IS RELATED TO THE PRODUCT BEING WRONGLY USED FOR HIGH-PRESSURE INJECTION. 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 20GAX1.16IN PRN SLM NPVC LEAKED AT SEPTUM ON (B)(6), 2023 IN THE RADIOLOGY DEPARTMENT CT ROOM TO THE PATIENT FOR CARDIAC CORONARY CTA EXAMINATION, THE RIGHT UPPER LIMB ELBOW TO GIVE AN INTRAVENOUS INDWELLING NEEDLE A PLACEMENT, WELL-FIXED USUALLY, THE CT ROOM IN THE PROCESS OF EXAMINATION OF HIGH-PRESSURE RE-WINNING SYRINGE TO GIVE IODOPHOROL INJECTION OF 70 ML, 0.9% SODIUM CHLORIDE INJECTION OF 40 ML OF INTRAVENOUS INJECTION, IN THE PROCESS OF INJECTION FOUND THAT THE PATIENT BLOOD VESSELS DID NOT SHOW, IMMEDIATELY GO IN TO VIEW, FOUND THAT THE PATIENT THE RIGHT SIDE OF THE ELBOW NEEDLE HANDLE OF THE NEEDLE PLUG OFF, RESULTING IN THE LIQUID DID NOT ENTER THE PATIENT'S BODY, THE NEEDLE TUBE BLEEDING OUTWARD, IMMEDIATELY PULL OUT THE NEEDLE, AND PRESSURE TO STOP BLEEDING, TIMELY EXPLANATION TO THE PATIENT AND HIS FAMILY, TO OBTAIN THE PATIENT'S CONSENT TO GIVE THE PATIENT'S LEFT UPPER LIMB INTO THE VENOUS NEEDLE ONE, WELL-FIXED USUALLY, AND THE SMOOTH CHECK IS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    453427 BD INTIMA-II 20GAX1.16IN PRN SLM NPVC INTRAVASCULAR CATHETER FOZ BD (SUZHOU) 3234067 00382903830572

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown