MAUDE Adverse Event Report: STERIS CORPORATION PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Respiratory Distress (2045); Skin Irritation (2076); Chemical Exposure (2570)

Event Date 09/04/2014

Event Type  No Answer Provided  

Event Description

The user facility reported that steris detergents are causing lab technicians respiratory and skin irritations.

Manufacturer Narrative

Affected employees reported swollen tongues, itchy noses, light headedness, skin and respiratory irritations, and bad tastes in their mouths.The employees visited the employee health center; none of the employees were administered treatment and all returned to work the same day.A steris account manager spoke with user facility and identified the product as prolystica 2x concentrate enzymatic presoak and cleaner.The prolystica 2x concentrate enzymatic presoak and cleaner label states, "warning: contains subtilisins (proteolytic enzyme).Irritating to eyes and skin.Prolonged or frequently repeated contact to subtilisins may cause allergic reaction in some individuals.Do not breathe spray mist.Use adequate ventilation to maintain levels below established exposure limit." section 3.4.2 of ansi/aami st58:2005/(r)2010 regarding the ventilation of processing areas and equipment states, "general room ventilation: chemical sterilants should be used in an area that is properly ventilated.Rooms in which chemical disinfection and sterilization are performed should be large enough to ensure adequate dilution of vapor and should have a minimum air exchange rate of 10 air exchanges per hour (local regulations may require a higher minimum exchange rate).Ideally, local exhaust ventilation should be located at the level of the point of discharge of the vapors and pull vapors away from the work area and not toward personnel in the room." the steris account manager identified that the product was used in a confined space.The facility is currently conducting an evaluation of the ventilation of the space; the results have not yet been released.

• Brand Name: PROLYSTICA 2X CONCENTRATE ENZYMATIC PRESOAK AND CLEANER
• Type of Device: CLEANER
• Manufacturer (Section D): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer (Section G): STERIS CORPORATION; 7501 page avenue; st. louis MO 63133
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4140612
• MDR Text Key: 4794671
• Report Number: 1937531-2014-00009
• Device Sequence Number: 1
• Product Code: FLG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Date Manufacturer Received: 09/04/2014
• 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