BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM

    MDR report key: 17436296 · Received August 1, 2023

    Report

    Report Number
    9610847-2023-00205
    Event Type
    Malfunction
    Date Received
    August 1, 2023
    Date of Event
    June 14, 2023
    Report Date
    August 8, 2023
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833368
    PMA / PMN Number
    K923702
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION SUMMARY: IT WAS REPORTED THE SAFETY DEVICE FAILED. AS A SAMPLE WAS NOT RETURNED, A THROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. IT IS RECOMMENDED TO PROVIDE THE DEFECTIVE SAMPLE OR PHOTO FOR A FURTHER INVESTIGATION OF THE INDICATED DEFECT AND FIND THE ROOT CAUSE TO PREVENT REOCCURRENCE OF THIS DEFECT AT THE END OF USER FACILITY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 383336, LOT 2122684. THE REVIEW REVEALED THERE WERE NO INTERNAL REJECTS RELATED TO THE REPORTED ISSUE BY THE CUSTOMER. ACCORDING TO THE QUALITY RECORDS ALL THE INSPECTIONS OF THE SAMPLING PLAN MET THE ACCEPTANCE CRITERIA. BASED ON THE INVESTIGATION, BD WAS NOT ABLE TO CONFIRM THE BY CUSTOMER¿S INDICATED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10

    Additional Manufacturer Narrative · 0

    E.1 INITIAL REPORTER PHONE #: (B)(6). H3. 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 · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AN ATTEMPT WAS MADE IN OBS ROOM 13 TO INSTALL A PERIPHERAL VENOUS ACCESS, WITH INTIMA 20 FROM THE BD SALF-T-INTIMA BRAND, IN WHICH DURING THE CATHETER INSERTION PROCEDURE, THE SAFETY DEVICE FAILED, BECAUSE WHEN TRYING TO REMOVE THE NEEDLE, EVEN PRESSING THE FIXATION WING, THE CATHETER WAS REMOVED COMPLETELY WITH SILICONE AND EXPOSED NEEDLE PASSING UNDER THE PROFESSIONAL'S FINGER, WITHOUT OCCURRENCE OF AN ACCIDENT AT WORK.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM EXPERIENCED SAFETY MECHANISM FAILURE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: AN ATTEMPT WAS MADE IN OBS ROOM 13 TO INSTALL A PERIPHERAL VENOUS ACCESS, WITH INTIMA 20 FROM THE BD SALF-T-INTIMA BRAND, IN WHICH DURING THE CATHETER INSERTION PROCEDURE, THE SAFETY DEVICE FAILED, BECAUSE WHEN TRYING TO REMOVE THE NEEDLE, EVEN PRESSING THE FIXATION WING, THE CATHETER WAS REMOVED COMPLETELY WITH SILICONE AND EXPOSED NEEDLE PASSING UNDER THE PROFESSIONAL'S FINGER, WITHOUT OCCURRENCE OF AN ACCIDENT AT WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2343889 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 2122684 00382903833368

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown