MAUDE Adverse Event Report: STERIS CORPORATION REVITAL-OX RESERT HLD; HIGH LEVEL DISINFECTANT

Lot Number 277543

Device Problem Insufficient Information (3190)

Patient Problem Malaise (2359)

Event Date 10/06/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A steris consumable territory manager went to the user facility and found that there was no issue with the product and it was being used for its intended purpose.However the technician identified that there were not adequate air exchanges in the room where the employees were stationed with the chemistry.Section 7 of the material safety data sheet for revital-ox resert hld for handling and storage states, "avoid all eye and skin contact and do not breathe vapor and mist.Provide good ventilation in process area to prevent formation of vapor." section 8: exposure controls/personal protection states, "respiratory protection: in case of insufficient ventilation, wear suitable respiratory equipment." section 4.1 states, "first-aid measures after inhalation: remove victim to fresh air and keep at rest in a position comfortable for breathing.If not breathing, give artificial respiration.Seek medical attention immediately." 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 director of chemical hygiene for the user facility agreed with the assessment and will address the air exchange issue.Additionally the user facility indicated that they did not believe the resert hld subject of the reported event was at fault.Rather the inadequate air exchanges and prolonged exposure to the product caused the reported event.The user facility is currently taking steps to address the air exchanges/ventilation issues.

Event Description

The user facility reported that their staff members were not feeling well when using resert hld.No medical treatment was sought or administered for the employees subject of the reported event.

• Brand Name: REVITAL-OX RESERT HLD
• Type of Device: HIGH LEVEL DISINFECTANT
• 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: 5188791
• MDR Text Key: 29875517
• Report Number: 1937531-2015-00011
• Device Sequence Number: 1
• Product Code: MED
• 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: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Lot Number: 277543
• Date Manufacturer Received: 10/07/2015
• 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