BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD INFUSION SET SA200 W/O LL¿

    MDR report key: 12921698 · Received December 2, 2021

    Report

    Report Number
    2243072-2021-02854
    Event Type
    Malfunction
    Date Received
    December 2, 2021
    Date of Event
    November 3, 2021
    Report Date
    January 14, 2022
    Manufacturer
    BECTON DICKINSON
    Product Code
    FPB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: AFTER FURTHER EVALUATION OF THE COMPLAINT, IT HAS BEEN DETERMINED THAT THE PREVIOUSLY SUBMITTED MFR REPORT# 2243072-2021-02854 WAS SENT IN ERROR THIS IS NOT A BD PRODUCT AND IS THEREFORE NOT REPORTABLE. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    OEM MANUFACTURER: 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. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INFUSION SET SA200 W/O LL¿ THERE WAS AN IV SET LOOSE CONNECTION, SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS A "DISCONNECTION OF THE CHAMBER AND SPIKE ON THE BASIC IV SET."

    Description of Event or Problem · 0

    IT WAS REPORTED WHEN USING THE BD INFUSION SET SA200 W/O LL¿ THERE WAS AN IV SET LOOSE CONNECTION, SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: THERE WAS A "DISCONNECTION OF THE CHAMBER AND SPIKE ON THE BASIC IV SET."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1819748 BD INFUSION SET SA200 W/O LL¿ INFUSION SET FPB BECTON DICKINSON 5006011

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown