BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I

    MDR report key: 12178830 · Received July 15, 2021

    Report

    Report Number
    9610847-2021-00331
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    May 11, 2021
    Report Date
    July 14, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    00382903833139
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    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 #: 1021363, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: 2021-02-25. MEDICAL DEVICE LOT #: UNKNOWN, MEDICAL DEVICE EXPIRATION DATE: UNKNOWN, DEVICE MANUFACTURE DATE: UNKNOWN. DATE RECEIVED BY MANUFACTURER: BD WAS INITIALLY MADE AWARE OF THIS COMPLAINT ON (B)(6) 2021. AT THAT TIME, BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER, IT WAS EVALUATED AS A NON-REPORTABLE INCIDENT. ADDITIONAL INFORMATION WAS LATER RECEIVED ON 2021-07-13 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. INVESTIGATION SUMMARY: BD RECEIVED NINETEEN REPRESENTATIVE SAMPLES FOR LOT 1021363 AND 3 REPRESENTATIVE SAMPLES FOR LOT 0351256 SUBMITTED FOR EVALUATION. REPORTED ISSUE WAS CONFIRMED FOR LOT 1021363 SINCE FOUR OF THE REPRESENTATIVE SAMPLES FAILED OUR INTERNAL TESTING BUT NOT CONFIRMED FOR LOT 0351256 SINCE NO SAMPLES FAILED OUR INTERNAL TESTING. THE OCCLUDED SAMPLES OF LOT 1021363 WERE FURTHER REVIEWED AND IT WAS REVEALED THAT SILICONE WAS CLOGGING THE CANULA. OUR INVESTIGATION DETERMINED THAT THE SILICONE FOUND WITHIN THE CANULA WAS INTRODUCED DURING ITS FORMING PROCESS. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. INVESTIGATION CONCLUSION: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS. ROOT CAUSE DESCRIPTION: THE SAMPLE WAS TESTED ACCORDING TO INTERNAL PROCEDURE SI-16SP PER OCCLUSION DURING THE TEST IT WAS DETECTED THAT THE UNIT WAS OCCLUDED DURING A FURTHER REVIEW IT OF THE UNIT IT WAS OBSERVED THAT THE CANNULA WAS CLOGGED BY SILICONE. THIS DEFECT COULD HAD BEEN PRODUCED DURING THE LUBRICATION PROCESS AN EXCESS OF SILICONE CAN LEAD TO AN OCCLUSION OF THE CANNULA WHEN IS ASSEMBLED, DURING AN INVESTIGATION THIS EXCESS OF SILICONE WAS BEING PRODUCED DURING THE FORMING OF THE CATHETER TIP. ACTIONS TAKEN: A RETRAINING/AWARENESS WAS CARRIED OUT IN PROCEDURE (B)(4), THIS TO PREVENT ACCUMULATION OF SILICONE IN THE CATHETER TO PREVENT OCCLUSION. RATIONALE: NO CAPA - BASED ON AN EVALUATION OF SEVERITY AND FREQUENCY, NO CORRECTIVE ACTION WAS PERFORMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I HAD SILICONE ON THE NEEDLE. THIS OCCURRED ON 3 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FROM INVESTIGATION: "THE OCCLUDED SAMPLES WERE FURTHER REVIEWED AND IT WAS REVEALED THAT SILICONE WAS CLOGGING THE CANULA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1074651 SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. SEE H.10 00382903833139

    Patients

    Seq Age Sex Outcome Treatment
    1