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

Model Number	46827
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A total of twenty eight (28) samples and one (1) dispenser box was received.The samples were evaluated under ambient light conditions.The samples arrived inside a crushed dispenser box.Two (2) samples arrived with detached head bands from the left (as worn) side.The bond points of the elastic are not damaged.The corner bonds of each mask appear separated.The remaining samples were inspected.The elastic of eight (8) random samples were tugged as if for donning.Two headbands detached.One tore and the other one detached from a separated corner bond.The corner bond from some of the other samples started to separate but did not completely separate.The device history records (dhr) evaluation was performed for the product code 46827 identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures and specifications then released by quality assurance.A quality nonconformance was not reported at the time of production.Root cause was incorrect setup.Notification was sent to manufacturing leaders for awareness.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 elastic straps seem to be faulty within the mask as they kept snapping.Multiple masks were tried to no avail.The product incident was 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 SMALL
• 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, coahuila, mexico ; MX
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17148611
• Report Number: 9616096-2023-00048
• Device Sequence Number: 20228242
• Product Code: MSH
• UDI-Device Identifier: 30680651468278
• UDI-Public: 30680651468278
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/16/2023

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: AM0180841
• 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: 08/31/2022
• Initial Report FDA Received Date: 06/16/2023
• 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