BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDO KIT

    MDR report key: 12737499 · Received November 2, 2021

    Report

    Report Number
    1423395-2021-00056
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 5, 2021
    Report Date
    November 8, 2021
    Manufacturer
    MEDLINE INDUSTRUIES LP
    Product Code
    NWR
    UDI-DI
    10193489375152
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SAMPLE RECEIVED 11/5/2021: THE CUSTOMER RETURNED A CASE OF UNUSED SAMPLES AND A BIOHAZARD BAG CONTAINING SEVERAL USED VALVES. DURING EVALUATION OF ALL OF THE RECEIVED SAMPLES THERE WAS NO OBSERVED PHYSICAL DAMAGE TO ANY OF THE UNUSED VALVES OR THEIR VENDOR PACKAGING. IN THE USED COMPONENTS, WE OBSERVED NO DAMAGE TO THE EXTERIOR OF THE VALVES AND NO NOTICEABLE DAMAGE TO THE CONNECTION ENDS. THIS ITEM IS A PRE-SEALED COMPONENT IN A KIT. THE INFORMATION IN THIS REPORT AND THE SAMPLE HAVE BEEN FORWARDED TO THE COMPONENT MANUFACTURER FOR FURTHER EVALUATION. THE ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE VALVES WERE INSERTED INTO THE SCOPE AS USUAL WITH NO DEVIATION FROM THE USUAL PROCEDURE. BEFORE THE PROCEDURES STARTED THE SCOPE WAS TESTED FOR FLUSHING AIR/CO2 INSUFFLATION. EVERYTHING WAS WORKING APPROPRIATELY UNTIL INSERTION OF THE SCOPE INTO THE PATIENT. AFTER INSERTION THE SCOPE WAS LEAKING/SPLATTERING WITH WATER VIA THE VALVES. THE CLINICIAN WAS NOT ABLE TO PUT AIR/CO2 INTO THE PATIENT TO SEE THE LUMEN. ACCORDING TO THE REPORTER THE SCOPE WAS WITHDRAWN, THE VALVES WERE CHANGED TO A DIFFERENT BRAND AND THE SCOPE WAS CHECKED AGAIN WITH NO DEFICIENCIES NOTED. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT OR DELAY. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO ADDITIONAL INFORMATION IS AVAILABLE. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED OR OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VALVES WERE LEAKING AND THE CLINICIAN COULD NOT INSUFFLATE USING CO2 WHEN DOING A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637308 ENDO KIT NWR MEDLINE INDUSTRUIES LP 10193489375152

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention