BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONNECTOR C35-O

    MDR report key: 11712808 · Received April 23, 2021

    Report

    Report Number
    3003152976-2021-00220
    Event Type
    Malfunction
    Date Received
    April 23, 2021
    Date of Event
    March 18, 2021
    Report Date
    April 14, 2021
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. INVESTIGATION SUMMARY: NO PHOTOS OR PHYSICAL SAMPLES THAT DISPLAY THE REPORTED CONDITION WERE AVAILABLE FOR INVESTIGATION. PRODUCT UNDERGOES INSPECTIONS THROUGHOUT THE MANUFACTURING PROCESS TO ENSURE THE QUALITY AND FUNCTIONALITY OF THE DEVICE. AS THE LOT INVOLVED IN THIS INCIDENT IS UNKNOWN, A DEVICE HISTORY REVIEW CANNOT BE PERFORMED, AND ADDITIONAL RETAINED SAMPLES CANNOT BE EVALUATED. BASED ON THE AVAILABLE INFORMATION WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE AT THIS TIME."

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CONNECTOR C35-O SEPARATED FROM THE MATING COMPONENT DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED V TUBING WITH OPTIMA CONNECTOR/INJECTOR WITH BLUE CLAMP INTACT BECAME DISCONNECTED FROM THE PATIENT'S PAC. BD 090 "O IV TUBING WITH OPTIMA CONNECTOR/INJECTOR WITH BLUE CLAMP INTACT BECAME DISCONNECTED FROM THE PATIENT'S PAC." 515070 AND 515052 DISCONNECTED WITH 515085 ATTACHED. NO SAMPLES OR LOT NUMBERS GIVEN"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    614506 CONNECTOR C35-O INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON, S.A. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1