BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WESTMED LLC

    MDR report key: 14161811 · Received April 20, 2022

    Report

    Report Number
    2028807-2022-00012
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 4, 2022
    Report Date
    April 20, 2022
    Manufacturer
    WESTMED LLC
    Product Code
    CBT
    Adverse Event
    Yes
    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: COMPLAINT HISTORY REVIEW SHOWS NO OTHER COMPLAINTS FOUND WITH THIS ISSUE FOR PRIOR 12 MONTHS. COMPLAINT COULD NOT BE CONFIRMED VIA PRODUCT TESTING ON RETURNED DEVICES. RA: RMA-20036 R4

    Description of Event or Problem · 0

    NEEDLE PROTECTION BREAKING RESULTING IN SHARPS EXPOSURE AND POTENTIAL NEEDLE STICKS.

    Description of Event or Problem · 0

    NEEDLE PROTECTION BREAKING RESULTING IN SHARPS EXPOSURE AND POTENTIAL NEEDLE STICKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277157 WESTMED LLC FULL KIT PULSET 3CC SYRINGE 23G X 1" SAFETY TIP 25U BH,, CBT WESTMED LLC 3373-91 081821N05

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other