BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM

    MDR report key: 20867836 · Received December 6, 2024

    Report

    Report Number
    3002601200-2024-00700
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 2, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BD SUZHOU (MDS)
    Product Code
    FOZ
    UDI-DI
    00382903830336
    PMA / PMN Number
    K200891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    1. DHR/BHR REVIEW LOT#4109454 1-THE PRODUCTS OF THIS BATCH WERE ASSEMBLED AT INTIMA II AUTO LINE 4 IN MAY 2024, AND PACKAGED AT R240 PACKAGE LINE AND CFS PACKAGE LINE IN MAY 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. 4-REVIEW INCOMING INSPECTION RECORDS OF CATHETER, NO ABNORMALITIES. (MATERIAL NUMBER: B5171AAAL, BATCH NUMBER: 4022038, 4022061, 4022064, 4053912- 2. NO DEFECTIVE SAMPLE AND PHOTO HAVE BEEN RECEIVED FOR THE COMPLAINT. 3. THE RETAINED SAMPLE OF THIS BATCH IS TAKEN FOR 45PSI LEAKAGE TEST, AND NO LEAKAGE IS FOUND AT THE CATHETER. PLEASE SEE THE ATTACHED 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. BECAUSE THE CRACKING STATE OF THE CATHETER CANNOT BE IDENTIFIED, THE ROOT CAUSE OF THE LEAKAGE AT THE CATHETER CANNOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM CATHETER WAS CRACKED AND LEAKING THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ON (B)(6) 2024, THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM WITH ¿DIZZINESS AND A FALL, ACCOMPANIED BY VOMITING¿; CT SUGGESTED: SMALL INFARCT FOCI AND SOFT FOCI IN THE BRAIN; ECG SUGGESTED: ACUTE MYOCARDIAL INFARCTION. "ORAL CLOPIDOGREL TABLETS AND ASPIRIN TABLETS, 300 MG EACH; PRODUCT REASONS (INCLUDING INSTRUCTIONS, ETC.) CHECK THE INTEGRITY OF THE NEEDLE AND FIND THAT THE SOFT CANNULA NEEDLE IS CRACKED; RULE OUT THE USE OF SECONDARY PUNCTURES, RULE OUT THE CAUSE OF VIOLENT OPERATION, AND DO NOT RULE OUT THE CAUSE OF THE PRODUCT ITSELF; REPLACE USE A NEW INDWELLING NEEDLE AND SELECT A NEW BLOOD VESSEL TO PUNCTURE AGAIN".

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119932 BD INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD SUZHOU (MDS) 4109454 00382903830336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown