BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM

    MDR report key: 11681724 · Received April 16, 2021

    Report

    Report Number
    9610847-2021-00157
    Event Type
    Malfunction
    Date Received
    April 16, 2021
    Date of Event
    March 18, 2021
    Report Date
    July 6, 2021
    Manufacturer
    BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
    Product Code
    FOZ
    UDI-DI
    30382903833369
    PMA / PMN Number
    K013800
    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 COMPLAINT OF FOREIGN MATTER BEING FOUND ON THE CATHETER TIP WAS RECEIVED FROM THE CUSTOMER. SAMPLES WERE PROVIDED BY THE CUSTOMER FOR INVESTIGATION. THROUGH VISUAL INSPECTION THE CUSTOMER COMPLAINT WAS VERIFIED. USING FTIR ANALYSIS, IT WAS DETERMINED A SILICONE SUBSTANCE WAS ON THE CATHETER TIP. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED LOT NUMBER 0171899. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. BD CONCLUDES THAT THE FOREIGN MATTER DETECTED BY THE CUSTOMER IS SILICONE THAT IS APPLIED DURING THE MANUFACTURING PROCESS. SILICONE IS APPLIED TO THE FINISHED PRODUCT TO AID IN THE INSERTION OF THE DEVICE BY THE END USER. THE SILICONE USED IS A MEDICAL GRADE SILICONE. A QUALITY ALERT WAS PERFORMED AND NOTIFICATION OF THE QUALITY ALERT WAS CARRIED OUT FOR INVOLVED PERSONNEL. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME. OUR QUALITY TEAM WILL CONTINUE TO MONITOR THE MANUFACTURING PROCESS FOR THIS DEFECT AND OTHER EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 7 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEMS HAD "GELATINOUS" FOREIGN MATTER ON THE CATHETER TUBE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: "AFTER OPENING PACKAGE, IT WAS FOUND THAT THERE WAS GELATINOUS SUBSTANCE AT THE TIP OF THE CATHETER TUBE, AND MULTIPLE PRODUCTS HAD THE SAME PROBLEM."

    Additional Manufacturer Narrative · 1

    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 · 1

    IT WAS REPORTED THAT 7 BD SAF-T-INTIMA¿ IV CATHETER SAFETY SYSTEMS HAD "GELATINOUS" FOREIGN MATTER ON THE CATHETER TUBE TIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "AFTER OPENING PACKAGE, IT WAS FOUND THAT THERE WAS GELATINOUS SUBSTANCE AT THE TIP OF THE CATHETER TUBE, AND MULTIPLE PRODUCTS HAD THE SAME PROBLEM"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578062 BD SAF-T-INTIMA IV CATHETER SAFETY SYSTEM INTRAVASCULAR CATHETER FOZ BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. 383336 0171899 30382903833369

    Patients

    Seq Age Sex Outcome Treatment
    1