MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD FLUIDSHIELD LEVEL 3 FOG-FREE SURGICAL MASK; ICP FACIAL PROTECTION PRODUCTS

Model Number	48207
Medical Device Problem Codes	Contamination (1120); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint is available for evaluation.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
A physician had debris fall from their mask onto sterile field.The sterile field had to be draped again.There was no patient harm as a result of this incident.This incident occurred prior to use with a patient.
Additional Manufacturer Narrative
One used sample was received inside a plastic bag.Together with the mask, orange fiber strands were inside the plastic bag.The majority of the orange fiber strands are loose; however, there are some strands that are bonded on the left side (as worn) of the mask seam.There were fifteen (15) unused samples received for evaluation.One (1) mask contains a piece of red tape which is adhered to the outside of the mask.The appearance is the material was spliced in that area and the red tape was included in the manufacturing of that mask.The other foreign materials are mentioned in the evaluation above as loose fibers.A device history record (dhr) review of complaint lot was performed.Manufacturing conducts visual and functional inspections throughout production.Sampling plan was determined using the ansi/asqz 1.4 to release the product.Visual inspection is performed based on aql 1.0 level s-4.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.As part of facility cleaning processes, surfaces are cleaned with 70% ipa minimally once per shift.A complaint trend analysis was performed for past 12 months, from january 2024 to january 2025.There have been no upward trends during the past 12 months for this issue.Notification of complaint was sent to manufacturing leaders for awareness.A quality alert was posted in the manufacturing area to notify personnel involved.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp-(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 an o&m halyard, inc.Product is defective or has caused serious injury.

• Brand Name: HALYARD FLUIDSHIELD LEVEL 3 FOG-FREE SURGICAL MASK
• 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: 21619361
• Report Number: 9616096-2025-00001
• Device Sequence Number: 8516182
• Product Code: FXX
• UDI-Device Identifier: 30680651482076
• UDI-Public: 30680651482076
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K111402
• 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,Followup
• Report Date (Section B): 04/29/2025

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: 48207
• Device Catalogue Number: 48207
• Device Lot Number: AM4260331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2025
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 04/29/2025
• 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