BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATELLICA VTR SYRINGES

    MDR report key: 20793061 · Received November 27, 2024

    Report

    Report Number
    2028807-2024-00075
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    September 16, 2024
    Report Date
    January 29, 2025
    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
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: SYRINGE. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 26 NOVT 2024 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS COMPLAINT DATABASE AND IS 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 A SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY. AIRLIFE'S INVESTIGATION FINDINGS STATES THAT "THE COMPLAINT OF "AFTER REMOVING AIR BUBBLES BLOOD WAS LEAKING THROUGH THE FILTER CAP AND HIT THE PATIENT'S ARM" REGARDING PART: 11561344 WAS NOT CONFIRMED. THE ROOT CAUSE COULD POSSIBLY BE THAT THE VENT HAD NO CMC MATERIAL PRESENT ON THE FILTER. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE LOW WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD. THERE HAVE BEEN 2 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

    H6: SYRINGE. THE PRODUCT INVOLVED IN THE REPORT HAS NOT BEEN RETURNED. A REVIEW OF THE DEVICE HISTORY RECORD IS IN-PROGRESS. ALL INFORMATION REASONABLY KNOWN AS OF 26 NOVT 2024 HAS BEEN INCLUDED IN THE HEALTH AUTHORITY REPORT. SHOULD ADDITIONAL INFORMATION BE OBTAINED A FOLLOW-UP HEALTH AUTHORITY REPORT WILL BE PROVIDED. THE INFORMATION PROVIDED BY SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS LLC. SUNMED HOLDINGS LLC. 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 SUNMED HOLDINGS COMPLAINT DATABASE AND IS 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 A SUNMED HOLDINGS LLC. PRODUCT IS DEFECTIVE OR CAUSES SERIOUS INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE ISSUE OCCURRED WHERE AFTER REMOVING AIR BUBBLES BLOOD WAS LEAKING THROUGH THE FILTER CAP AND HIT THE PATIENT'S ARM".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE ISSUE OCCURRED WHERE AFTER REMOVING AIR BUBBLES BLOOD WAS LEAKING THROUGH THE FILTER CAP AND HIT THE PATIENT'S ARM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2367975 ATELLICA VTR SYRINGES 3ML VENTED LUER SLIP SYRINGE, (~50IU)16.7IU/ML BALANCED HEPARIN, VENTED TIP CAP CBT WESTMED LLC 11561344 080422N91 00709078013362

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other