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 04/29/2016

Event Type  Injury  

Manufacturer Narrative

It was reported that 20 ml of diluted (0.5%) medivators intercept detergent was injected via syringe into the endoscope by the physician during a gastro procedure.There was an immediate attempt to suction the injected fluid out of the patient.Medivators chemistry director informed the facility that the side effects for chemical exposure via ingestion and the toxicity of intercept detergent at the delivered diluted concentration to the stomach/gut are minimal.Medivators intercept sds along with toxicity studies and related information on the components of intercept detergent were closely reviewed by medivators chemistry director prior to contacting this facility.The patient was hospitalized post-procedure.It was reported the patient had other issues that was cause for hospitalization unrelated to the chemical ingestion of intercept detergent.This complaint will be closely monitored within medivators complaint handling system.

Event Description

During a gastro endoscopic procedure, a patient received an injection of medivators intercept detergent via endoscope.Potential patient chemical ingestion exposure reported.

• 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: 5625107
• MDR Text Key: 44293922
• Report Number: 2150060-2016-00018
• Device Sequence Number: 1
• Product Code: FEB
• 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: user facility
• Reporter Occupation: Other
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• Report Date: 05/02/2016

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: Physician
• Device Model Number: ML02-0106
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2016
• Initial Date FDA Received: 05/03/2016
• 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
• Patient Outcome(s): Hospitalization; Required Intervention