BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ALARIS PUMP MODULE SMARTSITE INFUSION SET

    MDR report key: 18785224 · Received February 26, 2024

    Report

    Report Number
    9616066-2024-00316
    Event Type
    Malfunction
    Date Received
    February 26, 2024
    Date of Event
    January 11, 2024
    Report Date
    May 13, 2024
    Manufacturer
    SISTEMAS MEDICOS ALARIS S.A. DE C.V.
    Product Code
    FPA
    UDI-DI
    37613203012448
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF AWARENESS UPDATED TO 01/11/2024.

    Additional Manufacturer Narrative · 0

    IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED BY CUSTOMER THAT THE PRIMARY ISSUE IS THAT THE PRODUCT IS UNSEALED/OPEN AND NOT STERILE. SEVEN SAMPLES AND TWO PHOTOS OF THE PRODUCT 2420-0500 WERE RECEIVED FOR QUALITY INVESTIGATION. THE PHOTOS RECEIVED SHOW THAT THE PACKAGING IS NOT SEALED ON ONE END OF THE PACKAGING. ADDITIONALLY, FROM THE PHOTOS PROVIDED, THE LOT NUMBER LABEL IS NOT ON THE PRODUCT PACKAGING. THE SAMPLES RECEIVED CONFIRM THE PHOTOS THAT WERE SUBMITTED BY THE CUSTOMER. THE CUSTOMER COMPLAINT OF PACKAGE SEAL INTEGRITY POOR / QUESTIONABLE WAS VERIFIED. THE MANUFACTURING LOCATIONS WERE MADE AWARE OF THE ISSUE FOR FURTHER INVESTIGATION. A PROCESS REVISION WAS CONDUCTED AND THERE WERE NO REPORTED ISSUES OF A WEAK SEAL OR LACK OF LABEL. DUE TO THE MISSING LOT NUMBER LABEL, THE SPECIFIC TIME PERIOD OF THE PRODUCT PRODUCTION COULD NOT BE DETERMINED AND THE ROOT CAUSE FOR THE FAILURE COULD NOT BE DETERMINED. A QUALITY ALERT HAS BEEN ISSUED TO THE ASSEMBLY PERSONNEL INVOLVED IN THE MANUFACTURING OF THIS PRODUCT. A DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. 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

    MATERIAL#: 2420-0500 BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE PRIMARY ISSUE IS THAT THE PRODUCT IS UNSEALED/OPEN AND NOT STERILE. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO ITEM: 2420-0500. QUANTITY AFFECTED: 7 EA. SERIAL/LOT NUMBER: N/A. PO : 4516954020. ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PRIMARY ISSUE IS THAT THE PRODUCT IS UNSEALED/OPEN AND NOT STERILE. THE MISSING LOT#/EXPIRATION DATE IS SECONDARY. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER REPLY: THE SAMPLES WILL BE PACKED AT 233625 HOLMAN HWY, THEN SENT TO OUR OFFSITE WAREHOUSE WERE FEDEX/UPS DO REGULAR PICKUPS. ADDRESS OF (B)(6). YES THE PROBLEM WAS FIST NOTED ON JANUARY 11TH.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD ALARIS PUMP MODULE SMARTSITE INFUSION SET WAS OPENED AND STERILITY WAS COMPROMISED THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: THE PRIMARY ISSUE IS THAT THE PRODUCT IS UNSEALED/OPEN AND NOT STERILE. THE MISSING LOT#/EXPIRATION DATE IS SECONDARY.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED. MATERIAL#: 2420-0500, BATCH NUMBER#: UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE PRIMARY ISSUE IS THAT THE PRODUCT IS UNSEALED/OPEN AND NOT STERILE. VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INJURIES OR ADVERSE EVENT: NO. ITEM: 2420-0500. QUANTITY AFFECTED: 7 EA. PO : (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. REPORTED ISSUE: THE PRIMARY ISSUE IS THAT THE PRODUCT IS UNSEALED/OPEN AND NOT STERILE. THE MISSING LOT#/EXPIRATION DATE IS SECONDARY. CUSTOMER DISPOSITION REQUEST: CREDIT. CUSTOMER REPLY: THE SAMPLES WILL BE PACKED AT (B)(6), THEN SENT TO OUR OFFSITE WAREHOUSE WHERE FEDEX/UPS DO REGULAR PICKUPS. ADDRESS OF (B)(6). YES THE PROBLEM WAS FIST NOTED ON JANUARY 11TH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1629994 BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS S.A. DE C.V. UNKNOWN 37613203012448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown