BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA® VTR SYRINGES

    MDR report key: 20041059 · Received August 22, 2024

    Report

    Report Number
    2028807-2024-00029
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    April 23, 2024
    Report Date
    September 3, 2024
    Manufacturer
    WESTMED LLC
    Product Code
    CBT
    UDI-DI
    00709078013362
    PMA / PMN Number
    K822786
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 22 AUG 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY. THE COMPLAINT OF "BLOOD IS COMING OUT OF THE SYRINGE WHEN REMOVING AIR BUBBLES" REGARDING PART 11561344 WAS CONFIRMED. THE ROOT CAUSE COULD POSSIBLY BE A RESULT OF NO CMC MATERIAL IN VENT FILTER. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE MEDIUM WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 0 OTHER COMPLAINTS REGARDING THE SAME PART AND A SIMILAR ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A RESOLUTION LETTER WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

    Additional Manufacturer Narrative · 0

    ALL INFORMATION REASONABLY KNOWN AS OF 22 AUG 2024 HAS BEEN INCLUDED IN THIS HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY AIRLIFE. REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO AIRLIFE. AIRLIFE. HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE AIRLIFE COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN AIRLIFE PRODUCT IS DEFECTIVE OR CAUSED SERIOUS INJURY.

    Description of Event or Problem · 0

    BLOOD IS COMING OUT OF THE SYRINGE WHEN REMOVING AIR BUBBLES.

    Description of Event or Problem · 0

    BLOOD IS COMING OUT OF THE SYRINGE WHEN REMOVING AIR BUBBLES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1527965 ATELLICA® VTR SYRINGES 3ML VENTED LUER SLIP SYRINGE, (~50IU)16.7IU/ML BALANCED HEPARIN, VENTED TIP CAP CBT WESTMED LLC 11561344 051122N50 00709078013362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other