MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DEFOGGER; ANTI-FOG SOLUTION

Model Number 28-0101B

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (b)(4) was received indicating that the x-ray element separated from the anti-fog foam pad (finished good 28-0101b) during a procedure.The x-ray detectable strip fell into the patient but was located after detaching.There was no patient injury.A sample was unavailable to return for evaluation.The complaint investigator reviewed the work order for the reported lot number (48028715).There were 27 defects from this lot; however, these parts were rejected due to issues with the paper backing, which is unrelated to the reported event.No discrepancies were identified in the work order that could have contributed to the reported failure.No change has been made to the raw materials or the converting process for the anti-fog pad.The investigation is ongoing at this time.When new and critical information is available, this report will be updated.

Event Description

The x-ray detectable strip came off the anti-fog pad during a procedure.

Manufacturer Narrative

Root cause: the photo of the defective sample confirmed the reported defect.However, the sample itself was unavailable for evaluation.A root cause for the reported issue was unable to be determined.Corrective action: due to the root cause determination, a corrective action has not been taken.Investigation summary an internal complaint (call 46079) was received indicating that the x-ray element separated from the anti-fog foam pad (finished good 28-0101b) during a procedure.The x-ray detectable strip fell into the patient but was located after detaching.There was no patient injury.A sample was unavailable to return for evaluation.A photo of the defective product was received, but it did not aid in the investigation of the reported issue.The complaint investigator reviewed the work order for the reported lot number (48028715).There were 27 defects from this lot; however, these parts were rejected due to issues with the paper backing, which is unrelated to the reported event.No discrepancies were identified in the work order that could have contributed to the reported failure.No change has been made to the raw materials or the converting process for the anti-fog pad.The investigation is complete at this time.If new and critical information is available, this report will be updated.

Event Description

The x-ray detectable strip came off the anti-fog pad during a procedure.

• Brand Name: DEFOGGER
• Type of Device: ANTI-FOG SOLUTION
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 185 richardson way; maynardville TN 37807
• MDR Report Key: 8317853
• MDR Text Key: 136298168
• Report Number: 1060680-2019-00001
• Device Sequence Number: 1
• Product Code: OCT
• UDI-Device Identifier: 00749756301749
• UDI-Public: 00749756301749
• Combination Product (y/n): N
• PMA/PMN Number: K982465
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 28-0101B
• Device Lot Number: 48028715
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1