MAUDE Adverse Event Report: MEDIVATORS INC RAPICIDE OPA/28 HIGH-LEVEL DISINFECTANT

Model Number ML02-0127

Device Problem Use of Device Problem (1670)

Patient Problem Chemical Exposure (2570)

Event Date 04/06/2023

Event Type  malfunction  

Event Description

The user facility reported via chemtrec report that an employee ingested rapicide opa/28 high-level disinfectant that was present on an instrument that had not been properly rinsed.The employee reported a numbing and tingling sensation on their lips, tongue, and throat in addition to a poor taste in their mouth.The employee was advised to visit the emergency room.

Manufacturer Narrative

The lot number of the rapicide opa/28 high-level disinfectant was not provided.The reported event is attributed to improper rinsing practices by user facility personnel as stated in the instructions for use.The rapicide opa/28 high-level disinfectant instructions for use states, "rinsing instructions and procedure: 1.Manual reprocessing: following removal from rapicide opa/28 hld solution, thoroughly rinse the semi-critical device by immersing it in a large volume of water (e.G.8 liters).Use rinse water that is consistent with the directions provided below (see section 3).Keep the device entirely submersed for a minimum of 1 minute in duration, unless a longer time is specified by the reusable device manufacturer.Manually flush all lumens with large volumes (not less than 100 ml) of rinse water unless otherwise noted by the device manufacturer.Remove the device from the water and discard the rinse water.Always use fresh volumes of water for each rinse.Do not reuse the water for rinsing for any other purpose.Repeat the procedure for rinsing manual devices two additional times for a total of three (3) rinses with large volumes of fresh water to remove rapicide opa/28 hld residues.Proper rinsing devices is required, see warnings and precautions.Three (3) separate large volume water immersion rinses are required unless otherwise specified by device manufacturer's instructions.Refer to the reusable medical device manufacturer's labeling for additional rinsing instructions." the rapicide opa/28 high-level disinfectant label further provides the following language and guidance related to ingestion, "avoid ingestion or contamination of food.Ingestion may cause irritation or chemical burns of the mouth, throat, esophagus and stomach.If swallowed, do not induce vomiting.Drink large quantities of water and call a physician immediately." a copy of the safety data sheet was provided to the customer.Steris has offered in-service training on the proper use of the rapicide opa/28 high-level disinfectant, specifically proper rinsing instructions; however, we are awaiting a response from the user facility.A follow-up report will be submitted when additional information becomes available.

Manufacturer Narrative

Steris offered in-service training on the proper use of the rapicide opa/28 high-level disinfectant, specifically proper rinsing instructions; however, the user facility declined.No additional issues have been reported.

• Brand Name: RAPICIDE OPA/28 HIGH-LEVEL DISINFECTANT
• Type of Device: DISINFECTANT
• Manufacturer (Section D): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS INC; 14605 28th avenue n; minneapolis MN 55447
• Manufacturer Contact: daniel davy ; 14605 28th ave north; minneapolis, MN 55447 ; 4403927453
• MDR Report Key: 16875487
• MDR Text Key: 314626320
• Report Number: 2150060-2023-00027
• Device Sequence Number: 1
• Product Code: MED
• UDI-Device Identifier: 00677964054266
• UDI-Public: 00677964054266
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ML02-0127
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1