MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Model Number	ML02-0106
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Toxicity (2333); Chemical Exposure (2570)
Date of Event	12/21/2016
Additional Manufacturer Narrative
Medivators received (b)(4) report 12-21-2016.The facility reported that they possibly flushed a scope with intercept detergent while being used on a patent.(b)(4) provided the intercept detergent sds to the facility.Medivators ra contacted this facility and spoke with rn who called (b)(4).She reported that they were performing an upper gi endoscopy procedure.While switching scopes, there was confusion and intercept detergent might have been flushed into the scope into a patient.There was limited details provided regarding the specifics on how this occured.Base on information from medivators chemistry department, the side effects for chemical exposure via ingestion and the toxicity of intercept detergent are minimal when delivered at the recommended diluted concentration.There was no reported patient illness of injury.This complaint will continue to be monitored within medivators complaint system.
Event or Problem Description
The case states that during an upper gi endoscopy procedure, a scope may have possibly been flushed with intercept detergent while being used on a patient.Potential patient chemical exposure.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 6264485
• Report Number: 2150060-2017-00003
• Device Sequence Number: 19089488
• Product Code: FEB
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K102996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 01/19/2017

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: Nurse
• Device Model Number: ML02-0106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/21/2016
• Initial Report FDA Received Date: 01/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1