MAUDE Adverse Event Report: O&M HALYARD, INC. PFR P2 FILTERING RESPIRATOR YELLOW 50; ICP FACIAL PROTECTION PRODUCTS

Model Number	62408
Medical Device Problem Code	Device Unsafe to Use in Environment (2918)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint is not available.A follow-up report will be provided upon conclusion of the investigation.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 clinician reported that a member of the nursing staff was wearing a mask in a quarantine area for contagious diseases (covid).The blue elastic band holding the mask to the wearer's face suddenly broke.The nursing staff left the treatment area to re-mask.
Additional Manufacturer Narrative
According to the device history records, the product was manufactured according to the approved manufacturing procedures and lot was released by quality assurance.A quality nonconformance was not reported at the time of production.The operator documented a change on the machine sealer due to failures in seal of the elastic.Manufacturing conducts visual and functional inspections throughout production.A sampling plan ansi/asqz 1.4 is used to release product.Functional inspection is performed based on aql 0.65 level s-4 to assure compliance to applicable requirements.A sample evaluation was not conducted; however, based on the photographs provided, the customer complaint issue is confirmed.Complaints were analyzed through statistical analysis tool for the past 12 months from november 2023 to november 2024; there is no upward trend for this issue.The previous duckbill bonding process used a herrmann ultrasonics system, the space between the horn and the anvil is controlled by the system.The duckbill bonding process on the herrmann ultrasonics system was changed to improve the duckbill bonding process to have a more consistent bond.The new method system controls the force applied between the horn and the anvil; the position may vary depending on this force applied.The change was implemented after the complaint product was manufactured.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, 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.

• Brand Name: PFR P2 FILTERING RESPIRATOR YELLOW 50
• Common Device Name: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd; ste 320; 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 coggins ; 1220 old alpharetta rd; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 21104156
• Report Number: 9616096-2024-00004
• Device Sequence Number: 8665057
• Product Code: MSH
• UDI-Device Identifier: 30680651624087
• UDI-Public: 30680651624087
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 62408
• Device Catalogue Number: 62408
• Device Lot Number: AM1055801
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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