MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Model Number ML02-0106

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Toxicity (2333); Chemical Exposure (2570)

Event Date 12/21/2016

Event Type  No Answer Provided  

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 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
• Type of Device: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer (Section G): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• Manufacturer Contact: megan dickey ; 14605 28th ave n; minneapolis, MN 55447 ; 7635533327
• MDR Report Key: 6264485
• MDR Text Key: 65310391
• Report Number: 2150060-2017-00003
• Device Sequence Number: 1
• Product Code: FEB
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 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
• Device Operator: Nurse
• Device Model Number: ML02-0106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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