BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GP SERIES INFUSION SET, 1 SS Y

    MDR report key: 11244537 · Received January 28, 2021

    Report

    Report Number
    2243072-2021-00172
    Event Type
    Malfunction
    Date Received
    January 28, 2021
    Date of Event
    December 29, 2020
    Report Date
    February 26, 2021
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING INFORMATION HAS BEEN CORRECTED: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT THE GP SERIES INFUSION SET, 1 SS Y EXPERIENCED LEAKAGE. THIS DEVICE IS NOT MANUFACTURED WITHIN THE UNITED STATES AND IS NOT SIMILAR TO BD DEVICES REGISTERED OR SOLD WITHIN THE UNITED STATES. IT IS THEREFORE NOT SUBJECT TO FDA REPORTING REQUIREMENTS. THIS INCIDENT AND THE INITIAL MDR, (MFR REPORT # 2243072-2021-00172), CAN THEREFORE BE DISREGARDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COMPATIBILITY EVENT BETWEEN THE CENTRAL CATHETER WAS PRESENTED, SINCE THE STANDARD SET THE LUER LOCK CONNECTION CATCHES THE TIP OF THE CATHETER, BUT THERE IS FLUID DRAINAGE IN THIS CONNECTION, SO THERE IS A NEED TO USE A THREE-WAY VALVE; UNLIKE THE PHOTO PROTECTOR SET THAT DOES NOT HAVE THIS ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GP SERIES INFUSION SET, 1 SS Y EXPERIENCED LEAKAGE. THIS DEVICE IS NOT MANUFACTURED WITHIN THE UNITED STATES AND IS NOT SIMILAR TO BD DEVICES REGISTERED OR SOLD WITHIN THE UNITED STATES. IT IS THEREFORE NOT SUBJECT TO FDA REPORTING REQUIREMENTS. THIS INCIDENT AND THE INITIAL MDR, (MFR REPORT # 2243072-2021-00172), CAN THEREFORE BE DISREGARDED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COMPATIBILITY EVENT BETWEEN THE CENTRAL CATHETER WAS PRESENTED, SINCE THE STANDARD SET THE LUER LOCK CONNECTION CATCHES THE TIP OF THE CATHETER, BUT THERE IS FLUID DRAINAGE IN THIS CONNECTION, SO THERE IS A NEED TO USE A THREE-WAY VALVE; UNLIKE THE PHOTO PROTECTOR SET THAT DOES NOT HAVE THIS ISSUE.

    Additional Manufacturer Narrative · 1

    OEM MANUFACTURE: THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. MEDICAL DEVICE LOT #: AN INVALID LOT # OF 1017428 WAS PROVIDED BY THE INITIAL REPORTER, DEVICE EXPIRATION DATE: UNKNOWN. 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GP SERIES INFUSION SET, 1 SS Y EXPERIENCED LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A COMPATIBILITY EVENT BETWEEN THE CENTRAL CATHETER WAS PRESENTED, SINCE THE STANDARD SET THE LUER LOCK CONNECTION CATCHES THE TIP OF THE CATHETER, BUT THERE IS FLUID DRAINAGE IN THIS CONNECTION, SO THERE IS A NEED TO USE A THREE-WAY VALVE; UNLIKE THE PHOTO PROTECTOR SET THAT DOES NOT HAVE THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    138392 GP SERIES INFUSION SET, 1 SS Y INFUSION SET FPA BECTON DICKINSON 1017428

    Patients

    Seq Age Sex Outcome Treatment
    1