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

Model Number	46767
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
We received complaints about the quality of the mask.When handling the mask the elastic breaks.This incident occurred in the intensive care unit and it is very concerning.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
The product involved in the complaint was not returned for evaluation.The device history records (dhr) evaluation was performed for the product code 46767 identified in the complaint.The product was manufactured according to the approved manufacturing procedures and specifications.The product was released by quality assurance.A quality nonconformance was not reported at the time of production.A root cause was not identified.Manufacturing conducts visual and functional inspections throughout production aside from the qa inspection.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.H3 other text : device not returned.

• Brand Name: MASK PFR95 FS SS REG
• 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: 17140822
• Report Number: 9616096-2023-00056
• Device Sequence Number: 7662883
• Product Code: MSH
• UDI-Device Identifier: 30680651467677
• UDI-Public: 30680651467677
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K074068
• 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
• 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: 46767
• Device Catalogue Number: 991046767
• Device Lot Number: AM9186831
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/07/2020
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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