MAUDE Adverse Event Report: O&M HALYARD, INC. PFR95 PART FILT RESP; FLUIDSHIELD* N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

Model Number	46727
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The customer used the n-95 and the front seam of the duckbill mask is separating.This was reported to have occurred during use.Three attempts were made to obtain additional information from the reporter, however, the reporter did not provide response.The following medical device report is being filed retroactive to prior decision that this malfunction would be unlikely to result in a serious injury or illness.A reassessment of this incident has since found that should this malfunction recur in an isolation setting or during direct patient care, the end user may contract covid virus and thus be susceptible to a serious illness.For this reason this incident is being reported as a malfunction at this time.The reporter has indicated that no injury or illness resulted.
Additional Manufacturer Narrative
The product involved in the report was not available for return.As a result of the investigation, it was concluded that the most probable root cause was an adjustment in the sealer of the machine that caused a weak seal in the mask.The mask defect was not detected by the operator at the time of packaging the product.Notification was sent to manufacturing leaders for awareness.This product incident is documented in the complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that a product is defective or caused serious injury.H3 other text : device not returned.

• Brand Name: PFR95 PART FILT RESP
• Common Device Name: FLUIDSHIELD* N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; alpharetta GA 30005
• Manufacturer (Section G): LA ADA DE ACUNA; km 4.5 carreterra presa; la amistad; ciudad de acuna, ciudad de acuna 26220 ; MX 26220
• Manufacturer Contact: nicole early ; 1 edison drive; alpharetta, GA 30005
• MDR Report Key: 17088042
• Report Number: 9616096-2023-00044
• Device Sequence Number: 12238926
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K974068
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2022
• Initial Report FDA Received Date: 06/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown