MAUDE Adverse Event Report: BATTELLE MEMORIAL INSTITUTE N/A; RESPIRATOR, DECONTAMINATED

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Ccds staff and hcp are in discussion providing additional information concerning the decontamination process and what could cause deforming/creases as well proved an faqs link.Although no malfunction or serious injury of the decontaminated respirator has been confirmed, this report is required under the terms of the 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

User reported crease of the mask no longer under the outer seam of the mask, while there isn't a hole in the mask that you can see through, the seam is opened.The masks associated with this event were decontaminated with the battelle ccds "closed system" process.

• Brand Name: N/A
• Type of Device: RESPIRATOR, DECONTAMINATED
• Manufacturer (Section D): BATTELLE MEMORIAL INSTITUTE; 505 king ave; columbus OH 43201
• Manufacturer Contact: carl smerdel ; 505 king ave; columbus, OH 43201 ; 6144247950
• MDR Report Key: 11181459
• MDR Text Key: 240409260
• Report Number: 1523658-2021-00045
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1