BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED BD INFUSION SET

    MDR report key: 11067572 · Received December 23, 2020

    Report

    Report Number
    2243072-2020-02134
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    September 26, 2020
    Report Date
    December 10, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    UNKNOWN MANUFACTURER: (B)(4). MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. DEVICE MANUFACTURE DATE: UNKNOWN. (B)(4). INVESTIGATION SUMMARY: A SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION HOWEVER INFORMATION PROVIDED BY THE CUSTOMER INDICATES THAT LEAKAGE WAS OBSERVED FROM THE PRIMING VALVE OF A CME SET DURING INFUSION. THE MATERIAL AND LOT NUMBER OF THE AFFECTED PRODUCT WERE NOT PROVIDED TO ASSIST THE INVESTIGATION. A REVIEW OF THE CUSTOMER FEEDBACK DATABASE INDICATES THAT COMPLAINTS OF THIS NATURE ARE RARE AND THERE IS CURRENTLY NO TREND FOR ISSUES OF THIS NATURE AGAINST PRODUCTS MANUFACTURED AT THIS MANUFACTURING SITE. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE AS NO SAMPLES OR PHOTOS WERE RETURNED. ROOT CAUSE DESCRIPTION: THE DETAILS OF THIS FEEDBACK WERE FORWARDED TO THE LEGAL MANUFACTURER OF THE PRODUCT, CAESAREA MEDICAL ELECTRONICS LTD. FOR INVESTIGATION. THE ROOT CAUSE OF THE CUSTOMER¿S EXPERIENCE COULD NOT BE DETERMINED AS THE SAMPLE WAS NOT AVAILABLE FOR INVESTIGATION. IN THIS INSTANCE, WITHOUT A SAMPLE IT IS NOT POSSIBLE TO DETERMINE WHETHER A MANUFACTURING DEFECT COULD HAVE CAUSED OR CONTRIBUTED TO THE CUSTOMER¿S EXPERIENCE. THE LOT NUMBER WAS NOT AVAILABLE AND THEREFORE IT IS NOT POSSIBLE TO PERFORM A REVIEW OF THE PRODUCTION DOCUMENTATION FOR THIS PARTICULAR PRODUCT. RATIONALE: BASED ON THE INVESTIGATION, NO ADDITIONAL INVESTIGATION AND NO CAPA IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE UNSPECIFIED BD¿ INFUSION SET LEAKED AT THE PRIMER BUTTON. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE DEVICE SHOULD BE A SEALED UNIT TO DELIVER FLUIDS INTRAVENOUSLY TO ENSURE THE FLUID REMAINS STERILE. THE DEVICE W AS LEAKING AT THE PRIMER BUTTON."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526344 UNSPECIFIED BD INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1