BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD EXT SET OPAQUE 150CM PE

    MDR report key: 10069944 · Received May 19, 2020

    Report

    Report Number
    2243072-2020-00787
    Event Type
    Malfunction
    Date Received
    May 19, 2020
    Date of Event
    April 29, 2020
    Report Date
    October 6, 2020
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED REPORT MFR REPORT# 2243072-2020-00787 WAS SENT IN ERROR. THIS IS NOT 510K PRODUCT. PLEASE CONSIDER THE MDR CANCELLED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT WHEN CHANGING SYRINGE THE TUBING IS DAMAGED AND THE CONNECTION IS LOOSE WITH A BD EXT SET OPAQUE 150CM PE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMS THAT THE PROBLEM WITH THE EXTENSION TUBE IS THAT IT IS TWISTING CVK TUBE IN CIRCLES. ALSO WHEN YOU CHANGE THE SYRINGE (BBRAUN SYRINGE IN USE REF (B)(4)) TO A NEW ONE, THE SYRINGE DOES NOT FIT INTO THE CONNECTOR OF THE EXTENSION TUBE PROPERLY, THE CONNECTION REMAINS LOOSE.

    Additional Manufacturer Narrative · 1

    FOR OEM MANUFACTURING SITES: IN THIS MDR, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AS (B)(4) IS AN OEM MANUFACTURING SITE. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN CHANGING SYRINGE THE TUBING IS DAMAGED AND THE CONNECTION IS LOOSE WITH A BD EXT SET OPAQUE 150CM PE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER INFORMS THAT THE PROBLEM WITH THE EXTENSION TUBE IS THAT IT IS TWISTING CVK TUBE IN CIRCLES. ALSO WHEN YOU CHANGE THE SYRINGE (BBRAUN SYRINGE IN USE (B)(4)) TO A NEW ONE, THE SYRINGE DOES NOT FIT INTO THE CONNECTOR OF THE EXTENSION TUBE PROPERLY, THE CONNECTION REMAINS LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536907 BD EXT SET OPAQUE 150CM PE EXTENSION SET FPA BECTON DICKINSON 00104/5

    Patients

    Seq Age Sex Outcome Treatment
    1 Other