BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11168511 · Received January 13, 2021

    Report

    Report Number
    3006948883-2021-00097
    Event Type
    Malfunction
    Date Received
    January 13, 2021
    Date of Event
    December 17, 2020
    Report Date
    January 25, 2021
    Manufacturer
    BD (SUZHOU)
    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

    H6: INVESTIGATION SUMMARY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 0202480. 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. BD IS CURRENTLY INVESTIGATING POTENTIAL PROCESS CHANGES TO ELIMINATE THE OCCURRENCE OF SIMILAR EVENTS. SEE H.10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 204 INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS VISIBLE SILLICON OIL PARTICLE IN THE NEEDLE THE PROBLEM OCCURRED IN THE INTERNAL MEDICINE DEPARTMENT. AND ALL THESE LOT # OCCURED IN THE SAME DEPARTMENT.

    Additional Manufacturer Narrative · 1

    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: (B)(6) 2020. MEDICAL DEVICE LOT #: 9262116, MEDICAL DEVICE EXPIRATION DATE: 2022-11-06, DEVICE MANUFACTURE DATE: (B)(6) 2019. (B)(4). INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY THE FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER (B)(4) 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 SAMPLES 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. BD IS CURRENTLY INVESTIGATING POTENTIAL PROCESS CHANGES TO ELIMINATE THE OCCURRENCE OF SIMILAR EVENTS. INVESTIGATION CONCLUSION: IT CAN BE SEEN FROM THE RETURNED PICTURE THAT THERE IS WHITE FOREIGN BODY IN THE INDWELLING NEEDLE SURFACE . NO ACTUAL SAMPLE RETURNED, THE WHITE SUBSTANCE ON THE NEEDLE SURFACE CANNOT BE CONFIRMED BY CHEMICAL COMPOSITION ANALYSIS. ACCORDING TO THE CHARACTERISTICS OF SILICONE, DURING THE HIGH TEMPERATURE AND HUMIDITY , THERE MAY BE A LITTLE PRECIPITATE ON THE NEEDLE . BD'S MATERIALS LABORATORY IN THE UNITED STATES CONDUCTS A NORMATIVE TEST ON THE SILICONE USED IN THE PRODUCT PROCESS. THE TEST RESULTS SHOW THAT THE SILICONE IS A LUBRICANT FOR MEDICAL DEVICE PRODUCTS AND MEETS THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS. CHECK THE BATCH RECORD, RECORD OF IN-PROCESS INSPECTION AND FINAL INSPECTION. NO FINING ON RESIDUAL OF SILICONE ON THE NEEDLE . THE SILICONE IS A LUBRICANT FOR MEDICAL DEVICE PRODUCTS ,THE SUBSTANCE IS NON-TOXIC AND HARMLESS MEETS THE REQUIREMENTS OF RELEVANT ISO AND FDA STANDARDS. THE FACTORY WILL CONTINUE TO MONITOR SUCH DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 204 INTIMA-II Y 24GAX0.75IN PRN/EC SLM EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE WAS VISIBLE SILLICON OIL PARTICLE IN THE NEEDLE THE PROBLEM OCCURRED IN THE INTERNAL MEDICINE DEPARTMENT. AND ALL THESE LOT # OCCURED IN THE SAME DEPARTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55220 INTIMA-II Y 24GAX0.75IN PRN/EC SLM INTERVASCULAR CATHETER FOZ BD (SUZHOU) SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1