BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 21253744 · Received January 28, 2025

    Report

    Report Number
    3002601200-2025-00021
    Event Type
    Malfunction
    Date Received
    January 28, 2025
    Date of Event
    December 24, 2024
    Report Date
    February 24, 2025
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830626
    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. THE CUSTOMER HAS NO RETURNED SAMPLES AND PHOTOS. 2. DHR/BHR REVIEW LOT#4052078. 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN APRIL 2024, AND PACKAGED AT R240 PACKAGE LINE IN APRIL 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. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE REFER TO ATTACHMENT FOR THE TEST REPORT. 4. 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. SINCE THE DEFECTIVE SAMPLE IS NOT RETURNED, DEEP ANALYSIS FOR THIS COMPLAINT IS UNAVAILABLE, SO THE ROOT CAUSE OF LEAKAGE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO SAMPLE AVAILABLE. NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC LEAKED WITH POWER INJECTOR ON (B)(6) 2024, THE PATIENT UNDERWENT A CT ENHANCEMENT EXAMINATION, WHICH REQUIRED A VENOUS PUNCTURE NEEDLE TO INJECT IODINE CONTRAST BEFORE THE EXAMINATION. THE NURSE ON DUTY IN THE RADIOLOGY DEPARTMENT, JIANG HONGHUI, USED A 20G NEEDLE ACCORDING TO THE PATIENT'S VASCULAR CONDITION AND THE SPECIFIC EXAMINATION PROGRAM. THE PUNCTURE OPERATION WAS NORMAL, BUT AFTER PULLING OUT THE CORE OF THE INDWELLING NEEDLE, BLOOD LEAKAGE OCCURRED AT THE SEAL OF THE END OF THE INDWELLING NEEDLE. THE NURSE ON DUTY IMMEDIATELY USED SALINE TO FLUSH THE TUBE, BUT THERE WAS STILL BLOOD LEAKAGE, AND JUDGED THAT THIS PHENOMENON WAS DUE TO THE PRODUCT QUALITY OF THE INDWELLING NEEDLE, SO SHE PULLED OUT THE INDWELLING NEEDLE AND PRESSED ON THE PUNCTURE SITE. AFTER STOPPING THE BLEEDING, WITH THE PATIENT'S CONSENT, ANOTHER NEEDLE WAS USED TO RE-SELECT ANOTHER BLOOD VESSEL FOR PUNCTURE, AND THE PUNCTURE WAS SUCCESSFUL. THIS INCIDENT DELAYED THE PATIENT'S TREATMENT AND INCREASED THE PAIN OF REPEATED PUNCTURES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1441870 BD INTIMA-II Y 20GAX1.16IN PRN EC SLM NPVC INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4052078 00382903830626

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown