BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS SMARTSITE LOW SORBING SET

    MDR report key: 14142810 · Received April 19, 2022

    Report

    Report Number
    2243072-2022-00504
    Event Type
    Malfunction
    Date Received
    April 19, 2022
    Date of Event
    March 4, 2022
    Report Date
    August 2, 2022
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    50885403233812
    PMA / PMN Number
    K960280
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. 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. DEVICE EXPIRATION DATE: UNKNOWN. FDA NOTIFIED: THE INITIAL REPORTER NOTIFIED THE FDA VIA UF/IMPORTER REPORT#: (B)(4). 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.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED TWICE THAT THE BD ALARIS SMARTSITE LOW SORBING SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY TUBING COMING APART AT THE MANUFACTURED CONNECTIONS. D.1. MEDICAL DEVICE BRAND NAME: BD ALARIS SMARTSITE LOW SORBING SET D.3. MEDICAL DEVICE MANUFACTURER: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. D.4. MEDICAL DEVICE CATALOG #: 10013902 D.4. MEDICAL DEVICE LOT #: 21079014 D.4. MEDICAL DEVICE EXPIRATION DATE: 12-JUL-2024 D.4. UNIQUE IDENTIFIER (UDI) #: (B)(4). G.1. MANUFACTURING LOCATION: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. G.5. PMA / 510(K)#: K960280 H.4. DEVICE MANUFACTURE DATE: 09-JUL-2021 H.6. INVESTIGATION SUMMARY: THE CUSTOMER REPORTED THE TUBING CAME APART AT THE JUNCTION AND RETURNED TWO USED SAMPLES OF 10013902. THE SAMPLES WERE BOTH SEPARATED AT THE OUTLET OF THE FILTER, AND THE COMPLAINT IS VERIFIED. THE ROOT CAUSE WAS FOUND TO BE INSUFFICIENT SOLVENT APPLIED DURING THE ASSEMBLY PROCESS. NO OTHER FAILURE MODES OBSERVED. DEVICE HISTORY RECORD REVIEW FOR MODEL 10013902 LOT NUMBER 21079014 WAS PERFORMED. THE SEARCH SHOWED THAT A TOTAL OF (B)(4) UNITS IN 1 LOT NUMBER WAS BUILT ON 13JUL2021. THERE WERE NO QUALITY NOTIFICATIONS ISSUED FOR THE FAILURE MODE REPORTED BY THE CUSTOMER DURING THE PRODUCTION BUILD OF THIS SET. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE UNSPECIFIED BD TUBING SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY TUBING COMING APART AT THE MANUFACTURED CONNECTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TWICE THAT THE BD ALARIS SMARTSITE LOW SORBING SET EXPERIENCED COMPONENT SEPARATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CHEMOTHERAPY TUBING COMING APART AT THE MANUFACTURED CONNECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2717371 BD ALARIS SMARTSITE LOW SORBING SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 10013902 21079014 50885403233812

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown