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	10/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Five (5) random samples were inspected.The masks were opened and the elastic head bands were tugged with moderate force.None of the elastic head bands broke or detached from the corner bonds.The elastic remained securely attached inside the corner bonds and the corner bonds remained bonded together.A review of dhr production records was completed.Documented records show all visual and functional inspections were within specifications and there were no nonconformances documented during production of the complaint lot.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, 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 distributor reported that defective headbands tear during 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 or patient may be at an increased risk of contracting a pathogen.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.

• 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: 16865136
• Report Number: 9616096-2020-00013
• Device Sequence Number: 14807745
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: Other
• Device Model Number: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: AL0217511
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2020
• Initial Report FDA Received Date: 05/03/2023
• 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