BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 8800726 · Received July 17, 2019

    Report

    Report Number
    2243072-2019-01464
    Event Type
    Malfunction
    Date Received
    July 17, 2019
    Date of Event
    June 7, 2019
    Report Date
    August 15, 2019
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8233343. OUR RECORDS SHOW THAT THIS IS THE THIRD INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. ADDITIONALLY, ALTHOUGH A SAMPLE WAS NOT RECEIVED FOR THE PURPOSE OF OUR INVESTIGATION, ACCORDING TO PREVIOUS INVESTIGATIONS, THROUGH A VARIANCE IN THE AUTOLINE'S SWAGE PRESSURE IT IS POSSIBLE FOR THE MACHINE TO APPLY EXCESS FORCE TO THE DEVICE DURING ASSEMBLY, ALLOWING FOR THE RESULTING CRACK TO FORM IN THE DEVICE. CURRENTLY, WE ARE CONDUCTING A LONG TERM STUDY, CAPA#642738, TO DETERMINE THE ROOT CAUSE FOR THIS EVENT, BUT WE ARE ADDRESSING THE ISSUE THROUGH THE IMPLEMENTATION OF MANUAL INSPECTIONS FOR CRACKS IN THE ADAPTER HEAD, AND WE ARE FURTHER OPTIMIZING OUR SWAGING PROCESS BY REDUCING DEPTH REQUIREMENTS. H3 OTHER TEXT : SEE H.10.

    Additional Manufacturer Narrative · 0

    THE MEDICAL DEVICE MANUFACTURE, MEDICAL DEVICE CATALOG #/LOT #, DEVICE BRAND NAME, DEVICE EXPIRATION/MANUFACTURE DATE, UNIQUE IDENTIFIER (UDI)#, EVENT DESCRIPTION, AND PMA/510(K)# HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT LUER CONNECTION SITE BROKEN AND RESULT IN NORMAL MEDICATION LEAKAGE AFTER COMPLETED NEEDLE PENETRATION. D.1. MEDICAL DEVICE BRAND NAME: INTIMA-II Y 24GAX0.75IN PRN/EC SLM. D.3. MEDICAL DEVICE MANUFACTURER: SUZHOU CHINA; BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. D.4. MEDICAL DEVICE CATALOG #: 383033. D.4. MEDICAL DEVICE LOT #: 8233343. D.4. MEDICAL DEVICE EXPIRATION DATE: 2021-09-14. D.4. UNIQUE IDENTIFIER (UDI)#: (B)(4). G.1. MANUFACTURING LOCATION: SUZHOU CHINA; BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. G.5. PMA/510(K)#: N/A. H.4. DEVICE MANUFACTURE DATE: 2018-08-21.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT LUER CONNECTION SITE BROKEN AND RESULT IN NORMAL MEDICATION LEAKAGE AFTER COMPLETED NEEDLE PENETRATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT LUER CONNECTION SITE BROKEN AND RESULT IN NORMAL MEDICATION LEAKAGE AFTER COMPLETED NEEDLE PENETRATION.

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD CATHETER EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT'S NOTICED THAT LUER CONNECTION SITE BROKEN AND RESULT IN NORMAL MEDICATION LEAKAGE AFTER COMPLETED NEEDLE PENETRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594369 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 8233343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other