BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR C35-O

    MDR report key: 11980709 · Received June 10, 2021

    Report

    Report Number
    3003152976-2021-00324
    Event Type
    Malfunction
    Date Received
    June 10, 2021
    Date of Event
    May 11, 2021
    Report Date
    June 30, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY : NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR LOT 2012502, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS, INCLUDING TESTING TO VERIFY ALL CRITICAL DIMENSIONS ARE WITHIN SPECIFICATION SUCH AS THE LUER THREADING. RESULTS WERE REVIEWED FOR THE REPORTED LOT AND NO ISSUES WERE IDENTIFIED. FIVE RETAINED SAMPLES FROM LOT 2012502 WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO DAMAGE WAS OBSERVED ON THE PRODUCT AND ALL LUER DIMENSIONS WERE VERIFIED TO BE WITHIN THE REQUIRED SPECIFICATIONS. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO THE CONNECTOR OR OUR MANUFACTURING PROCESS AT THIS TIME. IT IS IMPORTANT TO ENSURE ALL LUER CONNECTIONS ARE SECURELY TIGHTENED BEFORE USE. COMPLAINTS RECEIVED FOR THIS DEFECT AND DEVICE WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CONNECTOR C35-O EXPERIENCED SEPARATION AT THE MATING COMPONENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "BD PHASEAL OPTIMA CONNECTOR (BD #515070) LUERED OFF THE BD MAXPLUS (BD #MP1000-C) DURING HOME INFUSION OF 5FU PUMP. PATIENT WAS ABLE TO LUER THE TWO PIECES BACK TOGETHER, BUT NOTIFIED NURSES AT THE END OF INFUSION."

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONNECTOR C35-O EXPERIENCED SEPARATION AT THE MATING COMPONENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "BD PHASEAL OPTIMA CONNECTOR (BD #(B)(4)) LUERED OFF THE BD MAXPLUS (BD #(B)(4)) DURING HOME INFUSION OF 5FU PUMP. PATIENT WAS ABLE TO LUER THE TWO PIECES BACK TOGETHER, BUT NOTIFIED NURSES AT THE END OF INFUSION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    876670 CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. 2012502

    Patients

    Seq Age Sex Outcome Treatment
    1