MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. PARKER BATH; BATH, HYDRO-MASSAGE

Model Number AL24000-CA

Device Problem Use of Device Problem (1670)

Patient Problems Chemical Exposure (2570); Eye Pain (4467)

Event Date 08/25/2022

Event Type  malfunction  

Event Description

Arjo received a customer complaint for parker bath where it was indicated that during cleaning the bathtub, the disinfectant sprayed into the caregiver¿s eyes.The caregiver had a burning sensation to left eye and a reddened conjunctiva.The eye was flushed with water and the caregiver was sent home to shower and continue rinsing.The caregiver was contacted the next day and she reported she did not require medical treatment.The eye was feeling better but still slightly reddened.

Manufacturer Narrative

Please note that previous medwatch reports for this product may have been submitted under the registration number (b)(4).Currently, these products are to be handled by arjohuntleigh abs complaint handling establishment and any medwatch reports will be submitted under registration #(b)(4).Collection of additional information is ongoing.The conclusions will be provided within the follow-up report once the investigation is completed.

Manufacturer Narrative

Arjo received a customer complaint for a parker bath where it was indicated that during the bathtub cleaning, the disinfectant sprayed into the caregiver¿s eye.The caregiver had a burning sensation to the left eye and a reddened conjunctiva.The eye was flushed with water and the caregiver was sent home to shower and continue rinsing.The caregiver was contacted the next day and informed that the eye was slightly red and no treatment was required.The facility reported that the parker bath disinfection handle had a faulty trigger that could be inadvertently left on.The trigger was left opened and sprayed into the caregiver's eyes.An arjo service technician contacted the facility after the event.It was indicated that the involved caregiver was not wearing protective equipment when the event occurred.According to the information received, the yellow disinfection handle was visually checked and no damages were noticed by the maintenance facility staff, however, the arjo representative found that the disinfection handle had the trigger internally blocked.The parker bath instruction for use (ifu) inform the user about the following actions which must be performed when specified to ensure that the product remains within its original manufacturing specification.According to the parker bath instructions for use (ifu): "actions before every use: (¿) if any part is missing or damaged - do not use the product" "every month: check/clean shower heads" additionally, the involved caregiver was not wearing protective equipment when the event occurred.The parker bath ifu warns: "warning: to avoid eye and skin damage, always use protective glasses and gloves.If contact occurs rinse with plenty of water.If eyes or skin becomes irritated, contact a physician.Always read the material safety data sheet of the disinfectant." from our evaluation, it can be concluded that the event was a result of product labelling not followed - the user was not wearing personal protective equipment at the time of event and was using a damaged disinfection handle.In summary, the device was not up to the manufacturer¿s specification during the event occurrence ¿ the disinfection handle was damaged.The bathtub was not used for patient hygiene at the time of the event, but it was prepared for use and in that way, it played a role in this event.This complaint was decided to be reportable due to splash the disinfectant solution towards the caregivers' eyes what in combination with not using protective equipment, resulted in the injury.

• Brand Name: PARKER BATH
• Type of Device: BATH, HYDRO-MASSAGE
• 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: justyna kielbowska ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 883337089
• MDR Report Key: 15444446
• MDR Text Key: 300583638
• Report Number: 3007420694-2022-00152
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: AL24000-CA
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/19/2022
• Supplement Dates Manufacturer Received: 08/26/2022
• Supplement Dates FDA Received: 10/13/2022
• Date Device Manufactured: 06/16/2015
• 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): Other