BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE EXTENSION SET

    MDR report key: 13214072 · Received January 10, 2022

    Report

    Report Number
    9616066-2021-52718
    Event Type
    Malfunction
    Date Received
    January 10, 2022
    Date of Event
    December 14, 2021
    Report Date
    January 19, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403242043
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20119639. MEDICAL DEVICE EXPIRATION DATE: 2021-11-25. DEVICE MANUFACTURE DATE: 2020-11-24. MEDICAL DEVICE LOT #: 21089079. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-08-31 MEDICAL DEVICE LOT #: 21089075. MEDICAL DEVICE EXPIRATION DATE: 2022-08-18. DEVICE MANUFACTURE DATE: 2021-08-18.

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER FACILITY NAME: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 20119639. MEDICAL DEVICE EXPIRATION DATE: 2021-11-25. DEVICE MANUFACTURE DATE: 2020-11-24. MEDICAL DEVICE LOT #: 21089079. MEDICAL DEVICE EXPIRATION DATE: 2022-08-31. DEVICE MANUFACTURE DATE: 2021-08-31, MEDICAL DEVICE LOT #: 21089075. MEDICAL DEVICE EXPIRATION DATE: 2022-08-18. DEVICE MANUFACTURE DATE: 2021-08-18.

    Additional Manufacturer Narrative · 0

    H.6. INVESTIGATION: NO PRODUCT OR PHOTO WAS RETURNED BY THE CUSTOMER. IT WAS REPORTED THAT THE SMARTSITE WILL NOT FLUSH. THE CUSTOMER COMPLAINT COULD NOT BE VERIFIED DUE TO THE PRODUCT NOT BEING RETURNED FOR FAILURE INVESTIGATION. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E-07 LOT NUMBER 20119639 WAS PERFORMED. THERE WAS ONE QUALITY NOTIFICATION ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E-07 LOT NUMBER 21089079 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEVICE HISTORY RECORD REVIEW FOR MODEL 22003E-07 LOT NUMBER 21089075 WAS PERFORMED. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. A DEFINITIVE ROOT CAUSE FOR THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED AS NO NEEDLE-FREE CONNECTOR (SMARTSITE) WAS RETURNED. FOLLOWING A SMALL NUMBER OF SIMILAR REPORTS, BD HAS CONDUCTED AN IN-DEPTH INVESTIGATION, CAPA#1998036 TO IDENTIFY ANY POTENTIAL CONTRIBUTING FACTORS FOR OCCLUSION OF THIS NATURE. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 4TH RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW ISSUES - FLUID BLOCKAGE WITH LOT #20119639 REGARDING ITEM #22003E-07. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW ISSUES - FLUID BLOCKAGE WITH LOT #21089079 REGARDING ITEM #22003E-07. A COMPLAINT HISTORY CHECK WAS PERFORMED AND THIS IS THE 1ST RELATED COMPLAINT REPORTED WITH THE DEFECT/CONDITION OF FLOW ISSUES - FLUID BLOCKAGE WITH LOT #21089075 REGARDING ITEM #22003E-07.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 3 BD ALARIS SMARTSITE EXTENSION SETS EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 3 DIFFERENT LOT NUMBERS THAT WON¿T FLUSH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 3 BD ALARIS SMARTSITE EXTENSION SETS EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 3 DIFFERENT LOT NUMBERS THAT WON¿T FLUSH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AT LEAST 3 BD ALARIS SMARTSITE EXTENSION SETS EXPERIENCED FLOW ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE 3 DIFFERENT LOT NUMBERS THAT WON¿T FLUSH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179204 BD ALARIS SMARTSITE EXTENSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 22003E-07 SEE H10 50885403242043

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown