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

Device Problem Chemical Spillage (2894)

Patient Problems Skin Irritation (2076); Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

Arjohuntleigh was made aware about an incident that took place in (b)(6) nursing.It was reported that during attempting to dilute cen kleen iv, some of the un-diluted product was reported to splash onto the skin of two staff members.They both felt a burning sensation to their skin but immediately washed off the undiluted product according to labeled instruction and no medical intervention or hospitalization was required.No information has been disclosed regarding the device that was attempted to be disinfected, but this product is recommended to be used with arjohuntleigh bathing systems.As the complaint description indicated involvement of two caregivers, separate complaint files have been created and evaluation of each event decided to be reported under (mfr rep no.3007420694-2017-00073 and mfr rep no.3007420694-2017-00074).An investigation was carried out into this complaint (mfr rep no.3007420694-2017-00074).When reviewing similar reportable events, we have found a very low number of cases that may relate to the issue investigated here: undiluted cen kleen iv disinfectant splashed onto the skin.Although there had never been reported serious injury in relation to similar inadequate sequence of actions taken by the caregiver, using cen kleen iv in that inappropriate way might cause skin burns or eye damage when splashed on the user.Therefore it was decided to report this complaint in abundance of caution.Cen-kleen iv is a hospital grade, "one step" quaternary ammonium-type disinfectant and cleaner containing blend of germicidal ingredients and detergents.It is designed for use with arjohuntleigh bathing systems and is a versatile choice for disinfection programs designed to reduce bacterial contamination of tubs, etc.In accordance to cen-kleen iv instruction for use presented on the product label, certain personal protective equipment shall be used: "hazards to humans and domestic animals.Danger.Corrosive.Causes irreversible eye damage and skin burns.Do not get in eyes, on skin or on clothing.Wear protective eyewear (goggles, face shield or safety glasses), protective (rubber or chemical resistant) gloves and protective clothing.Harmful if swallowed or absorbed through the skin." the product label also warns: "directions for use: it is a violation of federal law to use this product in a manner inconsistent with its labeling." in this particular complaint, the involved caregivers were not wearing protective clothing which represents using the product in a manner inconsistent with cen-kleen disinfectant labeling.From our evaluation we consider this event to be acting against the product labeling where the user was not wearing protective clothing and was not careful enough to avoid contact of the disinfectant with the skin.The received information and our evaluation as described above are showing that if instructions concerning product handling were followed in accordance to the labeling, there would be no patient or caregiver at risk.

Event Description

Arjohuntleigh was made aware about an incident that took place in (b)(6) nursing home.It was reported that during attempting to dilute cen kleen iv, some of the un-diluted product was reported to splash onto the skin of two staff members.They both felt a burning sensation to their skin but immediately washed off the undiluted product according to labeled instruction and no medical intervention or hospitalization was required.

• Brand Name: BATH
• Type of Device: BATH, HYDRO-MASSAGE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05 2; PL 62-052
• Manufacturer Contact: kinga stolinska ; ul. ks. piotra wawrzyniaka 2; komorniki, 62-05-2 ; PL 62-052 ; 98282467
• MDR Report Key: 6459717
• MDR Text Key: 71719342
• Report Number: 3007420694-2017-00074
• Device Sequence Number: 1
• Product Code: ILJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2017
• Distributor Facility Aware Date: 03/07/2017
• Event Location: Nursing Home
• Date Report to Manufacturer: 04/05/2017
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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