BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INTIMA-II 26GAX0.56IN MZ SLM NPVC

    MDR report key: 14502638 · Received May 25, 2022

    Report

    Report Number
    3014704491-2022-00200
    Event Type
    Malfunction
    Date Received
    May 25, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 14, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU
    Product Code
    FOZ
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D9: DEVICE AVAILABLE FOR EVAL YES, D9: RETURNED TO MANUFACTURER ON: 09-MAY-2022. H6: INVESTIGATION SUMMARY: ONE DEFECT SAMPLE WAS RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE SAMPLE RETURNED WAS IN AN UNOPENED PACKAGE OF LOT 0140319. FLUID WAS OBSERVED INSIDE THE HOUSING OF THE MAXZERO. A REVIEW OF THE INTERNAL MANUFACTURING DEVICE RECORDS AND RAW MATERIAL HISTORY FILES FOR THE REPORTED LOT NUMBER WAS PERFORMED AND NO RECORDED QUALITY PROBLEMS OR REJECTIONS TO THIS INCIDENT WERE FOUND. THE FLUID VISIBLE WITHIN THE MAXZERO IS CONSISTENT WITH THE MEDICAL-GRADE SILICONE WHICH IS USED AS A LUBRICANT IN THE MAXZERO PRODUCTS. THE APPLICATION OF SILICONE IS A CLOSELY REGULATED PROCESS AND THE WEIGHT OF THE SILICONE IS CHECKED AT REGULAR INTERVALS DURING THE MANUFACTURING OF THE MAXZERO COMPONENTS. THE EVALUATION OF THE BIOLOGICAL AND CHEMICAL DATA INDICATES THAT THE COMPONENT CAN BE CONSIDERED SAFE FOR CLINICAL USE. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II 26GAX0.56IN MZ SLM NPVC FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN PEDIATRICS, THERE IS WATER DROP IN CONNECTOR OF THE INDWELLING NEEDLE.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD INTIMA-II 26GAX0.56IN MZ SLM NPVC FOREIGN MATTER WAS FOUND IN THE FLUID PATHWAY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN PEDIATRICS, THERE IS WATER DROP IN CONNECTOR OF THE INDWELLING NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393076 BD INTIMA-II 26GAX0.56IN MZ SLM NPVC INTRAVASCULAR CATHETER FOZ BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU 0140319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown