MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. ARJO FLUSHER DETERGENT; WASHER OF BODY WASTE RECEPTACLES

Device Problem Use of Device Problem (1670)

Patient Problem Sore Throat (2396)

Event Date 10/10/2023

Event Type  Injury  

Event Description

Arjo was informed of an event involving arjo liquid flusher rinse and arjo liquid flusher detergent used with some other liquids (i.E.Clements chemicals - non arjo products) to clean the waste transfer station area.After washing the floor, the waste transfer station was closed overnight (without ventilation) and opened early in the morning by transport workers.Transport workers complained about sore eyes/throat.Additional information was received that some workers were given eye drops and ointment.Some of them required another visit to the eye clinic and some required care in the hospital.

Manufacturer Narrative

This report refers to arjo liquid flusher detergent.The report for arjo liquid flusher rinse was registered separately (under the internal record tw(b)(4)).Based on the information collected in the course of the investigation, the most likely cause of the event might be related to use error - product labeling not being followed (arjo liquid flusher detergent) intended for automatic rinsing of human waste containers was used to clean the floor.This is in line with the customer statement included in the customer report that the product was misused by trust employees.It should be underlined that the flushers are equipped with a dosing system (pump and hoses) and the dosage of arjo liquids is controlled by a microprocessor in the flusher.Following the flushers instruction for use (ifu) (e.G.For amigo flusher 60015000202_4en) : the arjo liquid flusher detergent is: "a mild alkaline detergent to be used for automated cleaning of human waste containers." "exercise caution when handling the chemical agent used in the machine.Follow the manufacturers' instructions or contact the manufacturer: if the agent comes into contact with the eyes or skin or if vapors are inhalated".In summary, the device (arjo liquid flusher detergent) was up to the manufacturer¿s specifications during the event.The product was not used for a patient hygiene at the time of the event.This complaint was decided to be reported to the competent authorities due to indication that staff members sustained serious injuries.

• Brand Name: ARJO FLUSHER DETERGENT
• Type of Device: WASHER OF BODY WASTE RECEPTACLES
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki PL-62 052; PL PL-62052
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 18265734
• MDR Text Key: 329719084
• Report Number: 3007420694-2023-00292
• Device Sequence Number: 1
• Product Code: FLH
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization