MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE - CCDS SITE CCDS CRITICAL CARE DECONTAMINATION SYSTEM; DECONTAMINATION SYSTEM FOR RESPIRATORS

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

Patient Problem Skin Discoloration (2074)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

A battelle critical care decontamination system (ccds) worker reported touching h2o2 without gloves.There was a small white mark on their hand.They did not experience any discomfort.The hand was flushed with water.The mark has since disappeared.No medical treatment required.This report is required under the terms of the battelle ccds (b)(4).All information known or reasonably known to battelle has been included in this submission.Any blank fields indicate that information was unavailable.

Event Description

A battelle critical care decontamination system (ccds) worker reported touching h2o2 without gloves.There was a small white mark on their hand.They did not experience any discomfort.No medical treatment was required.

• Brand Name: CCDS CRITICAL CARE DECONTAMINATION SYSTEM
• Type of Device: DECONTAMINATION SYSTEM FOR RESPIRATORS
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE - CCDS SITE; san antonio TX
• Manufacturer (Section G): CCDS SITE; san antonio TX
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11350084
• MDR Text Key: 233459671
• Report Number: 1523658-2021-00061
• Device Sequence Number: 1
• Product Code: QKY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other