MAUDE Adverse Event Report: O&M HALYARD, INC. MASK PFR95 FS SMALL; ICP FACIAL PROTECTION PRODUCTS

Model Number	46827
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The falure analysis lab received one (1) dispenser box of unused samples.A total of thirty five (35) samples were received.The original count on the dispenser box is thirty five (35).Product packaging was received.The samples were evaluated under ambient light conditions.The samples were removed and laid out on the lab table for inspection.The samples appear intact.The elastic head band of seven (7) random samples were tugged as if for donning.None of the elastic head bands broke or detached from the corner bonds, however the corner bonds of two samples separated slightly on the right side (as worn).The corner bond of four (4) additional samples were inspected.With little effort the corner bonds of all four samples separated, some more than others, on the right side (as worn).The elastic of the four samples remained bonded, however because the corner bonds separated with ease, the disposition will be confirmed.The device history records (dhr) evaluation was performed for the code 46827 and lot number am1318811 identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures and specifications.The product was released by quality assurance.A quality nonconformance was not reported at the time of production.Manufacturing conducts visual and functional inspections of each device throughout production aside from the qa inspection.The device was manufactured according to specification requirements.As a result of the investigation, it was concluded that the most probable root cause was an adjustment of the sealer by the operator, which caused a lack of seal in the mask.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, in compliance with the medical device reporting requirement and should not be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The customer utilizes the masks when seeing walk-in patients with respiratory symptoms and to perform covid tests.The customer reported the headband breaking off.Normally wears one mask a day but with this one mask it was replaced three times a day.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.Please note that in this incident, the reporter has indicated that no injury or illness resulted.

• Brand Name: MASK PFR95 FS SMALL
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• 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 amistadciudad de acuna; ciudad de acuna, coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17101721
• Report Number: 9616096-2023-00039
• Device Sequence Number: 7690828
• Product Code: MSH
• UDI-Device Identifier: 30680651468278
• UDI-Public: 30680651468278
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/09/2023

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: 46827
• Device Catalogue Number: 991046827
• Device Lot Number: AM1318811
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 06/09/2023
• 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