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	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
"i recently got a box of fluidshield 3 n95 partuculate filter respirator and surgical masks for my department's use.For some odd reason, this particular lot# (am0301811) has very weakly fastened straps that pop free of the mask with the slightest pressure.They are fastened into the sides of the mask much, much weaker than what i am normally used to with this mask.I've worn the same mask, but a different lot before and never had the straps pop loose like this before.They are popping loose from the mask on one side while just sitting there wearing them." this 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.
Additional Manufacturer Narrative
Two (2) unused samples were received with no product packaging.The elastic head bands appear securely bonded into the corner bonds of the masks.The elastic head bands were tugged as if for donning.The headbands did not detach from the corner bonds, however the right side (as worn) corner bonds started to separate after being tugged.The halyard stamp appears lightly stamped on the bottom of each sample.The most probable root cause was the incorrect position of the elastic headband which may impact the quality of the sealing of the elastic headband.The device history records (dhr) evaluation was performed for product code 46827 as 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.Manufacturing conducts visual and functional inspections throughout production.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.

• 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 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 17140846
• Report Number: 9616096-2023-00045
• Device Sequence Number: 7802451
• Product Code: MSH
• UDI-Device Identifier: 30680651468278
• UDI-Public: 30680651468278
• 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: 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: 46827
• Device Catalogue Number: 991046827
• Device Lot Number: AM0301811
• 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: 11/08/2021
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (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