MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Model Number	ML02-0106
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	03/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The facility reported a patient ingested intercept detergent during an endoscopy procedure when an endoscope flushed with intercept detergent was inserted back into the patient.The patient was exposed to the intercept detergent remaining in the endoscope.Medivators regulatory affairs contacted the facility after receiving the chemtrec report.The facility reported they obtained the safety data sheet (sds) and the patient was not experiencing any symptoms.They had contacted the (b)(6) regional poison control who advised them to give the patient water and juice and to monitor the patient for any symptoms related to the chemical exposure.Medivators ra followed up again with the facility and they reported the poison control contacted the patient and confirmed there were no symptoms from ingesting the intercept detergent and no medical attention was needed.The patient is reported to be doing fine.This complaint will continue being monitored in medivators complaint handling system.(b)(6).
Event or Problem Description
A facility reported a patient ingested intercept detergent during an endoscopy procedure when an endoscope flushed with intercept detergent was inserted back into the patient.The facility contacted their regional poison control and continued to monitor the patient after the incident occurred.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7421627
• Report Number: 2150060-2018-00029
• Device Sequence Number: 18841560
• Product Code: MNL
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date (Section B): 04/11/2018

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 the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/26/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other