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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Two (2) samples arrived with a handwritten number which matches the lot number reported.These samples appear intact.Three (3) samples arrived with the elastic head band completely detached from the left side (as worn).Five (5) samples were inspected and appear intact.The elastic head band was tugged as if for donning.There was no detachment of the elastic head bands.The head bands appear securely attached in both corner bonds.The disposition will be confirmed because some samples arrived with detached head bands.There is no damage observed on the bond points of the blue elastic head bands.The detachment of the elastic appears to come from the separation of the corner bond areas.The opposite corner bonds were inspected.The corners remained bonded and the elastic head bands appear securely attached.A review of dhr production records was completed.Pull strength headstrap tests are conducted per specification requiring 4.0lbs performance strength.The records from this lot show average of 5.0lbs (within specification).Documented records show all visual and functional inspections were within specifications and there were no nonconformances documented during production of the complaint lot.No root cause was identified.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 benconsidered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
Incident one.The straps were popping off at the seams when donning the small n95 mask.In less than a week, we also had 2 incidents where the mask broke while in a covid patients room.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 amistad; ciudad de acuna, coahuila, mexico 26220 ; MX 26220
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 16885576
• Report Number: 9616096-2023-00017
• Device Sequence Number: 17665236
• Product Code: MSH
• UDI-Device Identifier: 30680651468278
• UDI-Public: 30680651468278
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/05/2023

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: AM0178811
• 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: 01/14/2021
• Initial Report FDA Received Date: 05/08/2023
• 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