MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. MULTICLEAN; NONE

Model Number BPA1101-US

Device Problems Chemical Spillage (2894); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2015

Event Type  malfunction  

Event Description

It was initially reported by company representative that "the disinfection hose of the multiclean developed a pinhole and sprayed the caregiver in the face with disinfectant.The facility was reluctant to provide further info".As the customer was not willing to provide any detailed information, it was not possible also to perform a device examination.The customer requested only replacement of a shower hose.Despite several attempts it was not possible to provide detailed information as "they claim they have never been asked by a manufacturer for this type of information and do not want to provide it to us they say they will deal with it internally".However after the last attempt, the facility provided the following information: the employee was not wearing any ppe except for gloves - face shield/goggles are available in the tub room for employee use.The splash to her face only involved her cheek and did not contact any of her mucous membranes, eyes, ears - she did not report to the rn for first aid, but she said she treated herself by rinsing her cheek with soap and water and then continued on with her work.The facility did not receive an injury report because the employee did not report the incident through the workplace call center - she only reported the leaking tub hose via a maintenance work order.

Manufacturer Narrative

(b)(4).An investigation was carried out into this complaint.When reviewing similar reportable events for multiclean we haven't found any other similar cases: disinfectant splashing onto user's face.We find this complaint to be an isolated incident.The device found to be out of the specification - pinhole in a disinfection hose.The device was being used for cleaning other equipment and in that way contributed to the event.From received information no injury occurred as a result of this incident.(b)(4).The equipment is subject to wear and tear and the maintenance instructions listed in instruction for use must be performed when specified to ensure that the equipment remains within its original manufacturing specification.Poor maintenance: no other complaint for this device was found, it was also stated that the facility do ongoing maintenance throughout the year.After the incident where a spraying disinfectant was noted, customer contacted arjo service department, however user error cannot be ruled out fully despite of partially mitigated risk.As this kind of failure is easy to notice and if the second factor (protective equipment) was followed in accordance to product ifu, the risk of splashing the disinfectant would be wholly mitigated.Not following ifu's warnings: from the received information we can state that the customer did not use any protective equipment for face, only gloves.This is a negligence of correct and safe use of a device as per product labeling.The received information and our evaluation as described above are showing that if multiclean's warnings were followed in accordance to instruction for user, there would be no user at risk.

• Brand Name: MULTICLEAN
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; PL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4817952
• MDR Text Key: 5900326
• Report Number: 3007420694-2015-00109
• Device Sequence Number: 1
• Product Code: LRJ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 06/02/2015,05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BPA1101-US
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2015
• Distributor Facility Aware Date: 05/05/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 06/02/2015
• Date Manufacturer Received: 05/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• 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