MAUDE Adverse Event Report: O&M HALYARD, INC. PFR95 PART. FILTR MASK SM 35; ICP FACIAL PROTECTION

Model Number	46867
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One (1) unused sample was received with no product packaging.The sample was examined and compared to specification, component was found to be assembled according to the specification drawing.The sample was given a moderate tug while being inspected.The elastic head strap remained securely attached to the corner bond areas.The device history records (dhr) evaluation was performed for the product code 46867 identified in the complaint.According to the documented records, the product was manufactured according to approved manufacturing procedures and specifications.The product was released by quality assurance.A quality nonconformance was not reported at the time of production.Based on dhr review and manufacturing assessment, root cause is unknown.Manufacturing conducts visual and functional inspections throughout production aside from the qa inspection.The device was manufactured according to specification requirements.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, and should not be considered to be an admission that an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The customer reported issues with the ear loops breaking on both mask codes 47107 and 46867 during use.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.

• Brand Name: PFR95 PART. FILTR MASK SM 35
• Common Device Name: ICP FACIAL PROTECTION
• 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, coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17140842
• Report Number: 9616096-2023-00051
• Device Sequence Number: 7802449
• Product Code: MSH
• UDI-Device Identifier: 30680651468674
• UDI-Public: 30680651468674
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/15/2023

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: Health Professional
• Device Model Number: 46867
• Device Catalogue Number: 991046867
• Device Lot Number: AM7036812
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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