BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11168102 · Received January 13, 2021

    Report

    Report Number
    3006948883-2021-00080
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
    Product Code
    FOZ
    PMA / PMN Number
    NA
    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 THE REPORTED LOT NUMBERS. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THESE PRODUCTION BATCHES. 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, VISUAL EVALUATION OF THE SUBMITTED PHOTOS AND THE RESULTING REVIEW OF THE MANUFACTURING PROCESS DETERMINED THAT THE IDENTITY OF THE MATERIAL IS SOLIDIFIED SILICONE. SILICONE IS A MATERIAL USED TO MANUFACTURE THIS DEVICE, AND IS APPLIED TO THE CATHETER AS A LUBRICANT FOR REDUCED RESISTANCE DURING INSERTION. EXCESS APPLICATION OF THE LUBRICANT IS CURRENTLY POSSIBLE DUE TO LIMITATIONS IN THE MANUFACTURING PROCESS. H3 OTHER TEXT : SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 60 INTIMA-II Y 24GAX0.75IN PRN/EC SLM CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS VISIBLE SILLICON OIL PARTICLE IN THE NEEDLE GREEN CLAIMS ARE REQUIRED. THE PROBLEM OCCURRED IN INTERNAL MEDICINE DEPARTMENT."

    Additional Manufacturer Narrative · 1

    MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 0202480, MEDICAL DEVICE EXPIRATION DATE: 2023-08-10, DEVICE MANUFACTURE DATE: 2020-07-20. MEDICAL DEVICE LOT #: 9262116, MEDICAL DEVICE EXPIRATION DATE: 2022-11-06, DEVICE MANUFACTURE DATE: 2019-09-19. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 60 INTIMA-II Y 24GAX0.75IN PRN/EC SLM CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THERE WAS VISIBLE SILLICON OIL PARTICLE IN THE NEEDLE GREEN CLAIMS ARE REQUIRED. THE PROBLEM OCCURRED IN INTERNAL MEDICINE DEPARTMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    62626 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTRAVASCULAR CATHETER FOZ BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. SEE H.10

    Patients

    Seq Age Sex Outcome Treatment
    1