BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IV SET AN122 W/O PUMP T-TYPE

    MDR report key: 11659274 · Received April 13, 2021

    Report

    Report Number
    9616066-2021-50706
    Event Type
    Malfunction
    Date Received
    April 13, 2021
    Date of Event
    March 16, 2021
    Report Date
    April 15, 2021
    Manufacturer
    SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D10: DEVICE AVAILABLE FOR EVAL YES. D10: RETURNED TO MANUFACTURER ON: 2021-03-24. INVESTIGATION SUMMARY: 1 SAMPLE WAS RETURNED TO SBDM, LOT NUMBER IS 2012162. SBDM SUPPOSE THAT IT IS PARTICLE OF RUBBER PORT IN THE VIAL AS OF THE SAME MATERIAL OF RUBBER PORT IN THE VIAL. INFRARED SPECTROMETRY (IR) ANALYSIS: BASED ON INFRARED SPECTROMETRY (IR) ANALYSIS OF THE COMPLAINT SAMPLE, SBDM FOUND THE FM IS SAME COMPONENT WITH MATERIAL OF RUBBER PORT IN THE VIAL (LATEX GLOVES). HOUSE SAMPLE INSPECTION: SBDM CHECKED 30 HOUSE SAMPLES OF THE COMPLAINT PRODUCT (IV SET AN115 23G 1IN BP, LOT NO. 2012161, 2012162 AND 2101073), STORED IN THE COMPANY, THERE WAS NO DEFECTIVE PRODUCT FOUND IN THEM. DHR REVIEW: SBDM REVIEW THE MANUFACTURING RECORD OF COMPLAINT SAMPLE (LOT NO. 2012162), THERE IS NO ISSUE WHILE MANUFACTURING. CUSTOMER COMPLAINT RECORD REVIEW: SBDM THE CUSTOMER COMPLAINT RECORD OF COMPLAINT SAMPLE, THERE IS NO SIMILAR ISSUE OF THE SAME PRODUCT FROM OTHER CUSTOMER. ROOT CAUSE: SBDM CHECKED THIS COMPLAINT SAMPLE, THE LIKELY CAUSE IS THAT THE SPIKE WAS PIERCED THROUGH THE RUBBER PORT, FRAGMENT OF RUBBER PORT SEPARATED AND THEN IT FLOWED INTO THE I.V SET LINE. IT MIGHT BE OCCURRED WHEN TOO SHARP INJECTION HOLE IN THE SPIKE TIP IS PIERCED TOO SOFT VIAL RUBBER. AS PER KOREAN STANDARD AND SPECIFICATION OF MEDICAL DEVICE, THE IV SET HAS FILTER INSTALLED AT THE END OF LINE BEFORE THE ADAPTER RUBBER. AS THE FILTER SIZE IS 75 (200 MESH), THERE IS LITTLE POSSIBILITY THAT FOREIGN MATTER CAN FLOW INTO HUMAN BODY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE IV SET AN122 W/O PUMP T-TYPE EXPERIENCED FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL IN TUBE.

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 · 1

    IT WAS REPORTED THAT THE IV SET AN122 W/O PUMP T-TYPE EXPERIENCED FOREIGN MATTER IN FLUID PATHWAY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: FOREIGN MATERIAL IN TUBE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555621 IV SET AN122 W/O PUMP T-TYPE INTRAVASCULAR ADMINISTRATION SET FPA SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 2012162

    Patients

    Seq Age Sex Outcome Treatment
    1