MAUDE Adverse Event Report: MEDIVATORS INTERCEPT DETERGENT; ENDOSCOPE DETERGENT

Model Number	ML02-0106
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	12/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medivators received an incident report from chemtrec reporting that a patient experienced intravenous exposure to intercept detergent.There is potential for chemical exposure symptoms to occur.Chemtrec connected the caller with (b)(6) poison and control center for further assistance and provided the product's safety data sheet (sds).Medivators regulatory followed up with the facility and it was reported that the chemical exposure occurred when the patient was given an iv flush from a container that had intercept detergent added to it.It was reported that a technician began cleaning up after the patient procedure and poured intercept detergent into the iv flush container for disposal.Another technician, not knowing that intercept detergent had been added to the container, gave the patient an approximate 120 cc iv flush with the fluid in the container containing intercept detergent.It was reported that the patient experienced nausea which was treated with zofran and dilaudid.It was reported that the patient had no lasting symptoms.The facility reported that they are now following a strict new protocol to prevent an event like this from occurring again.This complaint will continue being monitored in medivators complaint handling system.
Event or Problem Description
Medivators received an incident report from chemtrec reporting that a patient experienced intravenous exposure to intercept detergent.There is potential for chemical exposure symptoms to occur.

• Brand Name: INTERCEPT DETERGENT
• Common Device Name: ENDOSCOPE DETERGENT
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 9489336
• Report Number: 2150060-2019-00074
• Device Sequence Number: 19296190
• Product Code: MNL
• UDI-Device Identifier: 00677964043086
• UDI-Public: 00677964043086
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/18/2019

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
• Device Model Number: ML02-0106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 12/18/2019
• 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