MAUDE Adverse Event Report: MEDIVATORS INC INTERCEPT DETERGENT

Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via chemtrec report that during a procedure a patient was exposed to intercept detergent that was present on a gastroscope that had not been properly rinsed.No report of injury or adverse effects and it is unknown if medical treatment was sought or administered.
Additional Manufacturer Narrative
The lot number of the intercept detergent was not provided.The reported event is attributed to improper rinsing practices by user facility personnel as stated in the instructions for use.Per the intercept detergent bottle label, "for cleaning of fully immersible endoscopes, related accessories, surgical instruments, and other apparatus where blood, mucus, protein or other hard to remove soils are encountered, use intercept¿ detergent at 1/3 oz./gal of water (0.25% use concentration) with one full stroke of the hand-pump (1 oz.) to three gallons of water.For best manual cleaning results, mix intercept¿ detergent with cool to warm water (20°c - 35°c) (68°f - 95°f) and ensure a minimum contact time of (1) one minute.Rinse all surfaces and internal channels thoroughly with water." the intercept detergent safety data sheet (sds) states (2/5), "precautions for safe handling: avoid contact with skin and eyes.Avoid breathing vapor or mist.Do not swallow." the sds further states (2/5), "symptoms/effects after ingestion: may be harmful if swallowed.May cause stomach distress, nausea, or vomiting." steris offered in-service training on the proper use of intercept detergent, specifically proper rinsing instructions for instruments; however, the user facility declined.No additional issues have been reported.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: DETERGENT
• 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: 17444604
• Report Number: 2150060-2023-00038
• Device Sequence Number: 2711796
• Product Code: MNL
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Initial Report FDA Received Date: 08/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown