MAUDE Adverse Event Report: O&M HALYARD, INC. MASK PFR95 FS SMALL; ICP FACIAL PROTECTION

Model Number	46827
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The straps are breaking off at the corner of the mask, and coming undone during use.The corner is not glued.The masks are used in covid+ rooms during pt/ot/slp sessions.The masks break during initial thirty minutes of 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
One (1) used sample was received with no product packaging.The sample was evaluated under ambient light conditions.The sample arrived with the elastic head band completely detached from the left side of the mask.There is no damage observed on the bond points of the blue elastic head band.The detachment of the elastic appears to come from the separation of the corner bond area.The opposite corner bond was inspected.The corners appear slightly separated but the head bands are still attached inside the corner bond.The inside of the mask was inspected.The inside layers appear securely bonded inside the mask.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.Notification was sent to manufacturing leaders for awareness.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, 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: ICP FACIAL PROTECTION
• 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: 17435620
• Report Number: 9616096-2023-00082
• Device Sequence Number: 6834747
• 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): 08/01/2023

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: AM0195841
• 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: 11/18/2020
• Initial Report FDA Received Date: 08/01/2023
• 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