MAUDE Adverse Event Report: O&M HALYARD, INC. PFR95 PART FILT RESP; ICP FACIAL PROTECTION PRODUCTS

Model Number	46727
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
While the nurse was providing patient care on a covid positive patient, the straps broke at the corner of the mask.The clinician reported no injury, no symptoms, no medical intervention or medical testing or treatment performed.The customer reported that this has occurred over the past several months and the clinicians were stapling the straps to the masks, they have since discontinued that practice.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.
Additional Manufacturer Narrative
The product involved in the event was not available for return.The content of this issue, the straps broke at the corner of the mask, was forwarded to the appropriate functional area for investigation and root cause determination.Based on the results of the investigation, a sample was not provided and the product could not be evaluated.A device history record evaluation was performed from the lot number reported which showed that the product was manufactured according to approved procedures, specifications and then released by quality assurance.Notification was sent to manufacturing leaders for awareness purposes only.We will continue to monitor the field performance of this product.A root cause was not 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 be considered to be an admission that a o&m halyard, inc.Product is defective or has caused serious injury.H3 other text : device not returned.

• Brand Name: PFR95 PART FILT RESP
• 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: 16885416
• Report Number: 9616096-2023-00022
• Device Sequence Number: 20376933
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Nurse
• 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: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: AL0215511
• 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: 02/10/2021
• Initial Report FDA Received Date: 05/08/2023
• 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: Female