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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Burn(s) (1757); Skin Discoloration (2074)

Event Date 08/03/2020

Event Type  malfunction  

Manufacturer Narrative

A battelle critical care decontamination system (ccds) worker reported a minor chemical burn and temporary skin discoloration on their hand from contact with h2o2.Another worker was wearing ppe including gloves and noticed a little h2o2 on the top of the ccds bioquell unit bottle during the puncturing of the seal process.A drop of h2o2 landed on the worker's glove which transferred to the pen that the worker was using to fill out forms.Another worker, who was not wearing gloves, picked-up the same pen and came in contact with the h2o2 that was on the pen.The worker went to the er, but no medical treatment was needed.This report is required under the terms of the battelle ccds eua.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 a minor chemical burn and temporary skin discoloration on their hand from contact with h2o2.The worker went to the er, but no medical treatment was needed.

• Brand Name: CCDS CRITICAL CARE DECONTAMINATION SYSTEM
• Type of Device: DECONTAMINATION SYSTEM FOR RESPIRATORS
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE - CCDS SITE; burbank CA
• Manufacturer (Section G): CCDS SITE; burbank CA
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11350088
• MDR Text Key: 234024795
• Report Number: 1523658-2021-00075
• 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: 02/18/2021

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: 08/03/2020
• 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