BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WESTMED LLC

    MDR report key: 14161512 · Received April 20, 2022

    Report

    Report Number
    2028807-2022-00010
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 20, 2022
    Manufacturer
    WESTMED
    Product Code
    CBT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THERE IS POTENTIAL CONTAMINATION TO PATIENT AND CLINICIAN. THIS WOULD CAUSE FOR THE PROCESS TO BE REPEATED. BASE ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAS BEEN MET.

    Additional Manufacturer Narrative · 0

    THERE IS POTENTIAL CONTAMINATION TO PATIENT AND CLINICIAN. THIS WOULD CAUSE FOR THE PROCESS TO BE REPEATED. BASE ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAS BEEN MET. SUMMARY: NO OTHER COMPLAINTS FOUND FOR PRIOR YEAR. UNABLE TO RECREATE OR CONFIRM COMPLAINT VIA PRODUCT TESTING. RA: (B)(4).

    Description of Event or Problem · 0

    SYRINGE WITH A HOLE IN THE SIDE. SQUIRTED BLOOD ON PATIENT AND CLINICIAN. DELAY IN TREATMENT AND POSSIBLE BLOOD CONTAMINATION.

    Description of Event or Problem · 0

    SYRINGE WITH A HOLE IN THE SIDE. SQUIRTED BLOOD ON PATIENT AND CLINICIAN. DELAY IN TREATMENT AND POSSIBLE BLOOD CONTAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277155 WESTMED LLC FULL KIT PULSET 3CC SYRINGE 23G X 1" SAFETY TIP 25U BH CBT WESTMED 3373-91 101221N11

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other