BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 9414814 · Received December 5, 2019

    Report

    Report Number
    3006948883-2019-01022
    Event Type
    Malfunction
    Date Received
    December 5, 2019
    Date of Event
    November 14, 2019
    Report Date
    March 9, 2020
    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 SUMMARY: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9023815. OUR RECORDS SHOW THAT THIS IS THE ONLY 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 THE SLEEVE STOPPER OF THE SUBMITTED SAMPLE ARRIVED UNATTACHED TO THE HEPARIN CAP; OUR QUALITY ENGINEERS WERE ABLE TO IDENTIFY NUMEROUS MULTIPLE POTENTIAL CAUSES RELATED TO VARIANCES IN THE MANUFACTURING PROCESS. CAPA 1389644 HAS BEEN LAUNCHED TO IDENTIFY THE ROOT CAUSE FOR THE OBSERVED NON-CONFORMITY; PRESENTLY BD HAS IMPLEMENTED THE APPROPRIATE CHANGES TO MANUFACTURING PRACTICES TO PREVENT A REOCCURRENCE OF THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED A LOOSE PRN WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HEPARIN CAP FELL OFF DURING INFUSION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED A LOOSE PRN WHICH WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE HEPARIN CAP FELL OFF DURING INFUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1215667 INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC INTERVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. 9023815

    Patients

    Seq Age Sex Outcome Treatment
    1 Other