BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 12345344 · Received August 19, 2021

    Report

    Report Number
    9610847-2021-00383
    Event Type
    Malfunction
    Date Received
    August 19, 2021
    Date of Event
    June 7, 2021
    Report Date
    August 18, 2021
    Product Code
    FOZ
    UDI-DI
    00382903833139
    PMA / PMN Number
    K013800
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 2021-08-17 THAT CHANGED THE REPORTABILITY DETERMINATION. BASED ON THE ADDITIONAL INFORMATION RECEIVED, THIS COMPLAINT IS NOW CONSIDERED TO BE AN MDR REPORTABLE INCIDENT. MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1053923, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1050825, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1021363, MEDICAL DEVICE EXPIRATION DATE: 2025-01-31, DEVICE MANUFACTURE DATE: (B)(6) 2021. MEDICAL DEVICE LOT #: 1053925, MEDICAL DEVICE EXPIRATION DATE: 2025-02-28, DEVICE MANUFACTURE DATE: (B)(6) 2021. INVESTIGATION SUMMARY: BD RECEIVED 542 SAMPLES SUBMITTED FOR EVALUATION. REPORTED ISSUE WAS CONFIRMED UPON TESTING OF THE SAMPLES. DURING TESTING 31 UNITS WERE OCCLUDED. FURTHER EXAMINATION SHOWED THAT EXCESS SILICONE FROM OUR LUBRICATION PROCESS WAS FOUND WITHIN THE CANNULA, RESULTING IN OCCLUSION. A DEVICE HISTORY RECORD REVIEW SHOWED NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING THE PRODUCTION OF THIS BATCH. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. 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: CORRECTIVE ACTIONS HAVE BEEN INITIATED TO INVESTIGATE THIS TYPE OF INCIDENT AND IDENTITY THE ROOT CAUSE. 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. RATIONALE: CAPA # (B)(4) WITH CAPA DETERMINATION WAS CREATED FOR FLASHBACK (POOR ¿ NO) DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE BLOOD RETURN IS SLOW. PER COMPLAINT DETAILS RECEIVED: THE NURSES HAVE NOTICED THAT THE BLOOD RETURN IS SLOWER WITH THESE LOT NUMBERS WHICH MAKES THE NURSES THINK THEY HAVE BLOWN THE VEIN AND WILL NEED TO RESTICK THE PATIENT. THEY HAVE TROUBLESHOOTED THIS ISSUE BY WITHDRAWING THE NEEDLE WITH SOMETIMES HELPS WITH THE BLOOD FLOW. FROM INVESTIGATION: BD RECEIVED 113 SAMPLES SUBMITTED FOR EVALUATION. REPORTED ISSUE WAS CONFIRMED UPON TESTING OF THE SAMPLES. DURING TESTING 17 UNITS WERE OCCLUDED. FURTHER EXAMINATION SHOWED THAT EXCESS SILICONE FROM OUR LUBRICATION PROCESS WAS FOUND WITHIN THE CANNULA, RESULTING IN OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1240160 SAF-T-INTIMA W/Y ADAPTER YEL 24GA X .75I INTRAVASCULAR CATHETER FOZ SEE H.10 00382903833139

    Patients

    Seq Age Sex Outcome Treatment
    1