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

Model Number	46767
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
Incident two: the product sample involved in the complaint was not available for return.The device history records (dhr) evaluation was performed for the code 46767 identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures and specifications.This product was released by quality assurance.A quality non conformance was not reported at the time of production.The acceptance criteria requires greater than 4 lbs.Pull strength results during in-process testing and final release testing well exceeded the specification requirements.Manufacturing conducts visual and functional inspections of each device throughout production aside from the qa inspection.The device was manufactured according to specification requirements.No root cause was found throughout process.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.H3: other text : device not returned.
Event or Problem Description
Incident two: the covid unit at (b)(6) hospital, a part of the moses cone system, has been experiencing product issues with the halyard n95 mask 46767.Staff is reporting the straps are breaking when trying to wear the masks.The staff are given one mask per shift but sometimes have to use two-three because of breaking.The masks are used to enter covid positive patient rooms.The mask breaks were reported to have occurred 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.The reporter has indicated that no injury or illness resulted.

• Brand Name: MASK PFR95 FS SS REG
• 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 amistad; ciudad de acuna, coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005
• MDR Report Key: 17101725
• Report Number: 9616096-2023-00037
• Device Sequence Number: 7690832
• Product Code: MSH
• UDI-Device Identifier: 30680651467677
• UDI-Public: 30680651467677
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Other Health Care 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: 46767
• Device Catalogue Number: 991046767
• Device Lot Number: AM1054831
• Was Device Available for Evaluation?: No
• 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: 05/10/2021
• Initial Report FDA Received Date: 06/09/2023
• 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 Age: 35 YR
• Patient Sex: Female
• Patient Weight: 77 KG