MAUDE Adverse Event Report: O&M HALYARD, INC. PFR95 PART FILT RESP; FLUIDSHIELD* N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK

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	10/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Three (3) used samples were received.The samples are kimberly clark branded.The section of the dispenser box with the lot number was received.The samples were evaluated under ambient light conditions.None of the masks arrived with head straps.The head straps appear to have been torn or broken at the corner bonds on all the masks.There are small greenish pieces of what appear as residual head strap material inside each mask.The corner bond of one mask was separated manually to inspect the area further.There are pieces of head band material inside the corner bond.The separated section of the corner bond was viewed under magnification.The head band material appears brittle and decayed and broken into little pieces.The device history records (dhr) evaluation was performed for the code 46727 identified in the complaint.According to the documented records, the product was manufactured according to approved manufacturing procedures and specifications then released by quality assurance.A quality nonconformance was not reported at the time of production.The investigation was carried out based on the sample evaluation, in which it was demonstrated that masks provided corresponds to kimberly clark product.The last lot number produced for code 46727 by kimberly clark was on december 17, 2016.A root cause is the headbands lost its properties for use.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.
Event or Problem Description
Ear loops came off while being worn, during use.There was no medical treatment or surgical intervention required.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.The reporter has indicated that no injury or illness resulted.

• Brand Name: PFR95 PART FILT RESP
• Common Device Name: FLUIDSHIELD* N95 PARTICULATE FILTER RESPIRATOR AND SURGICAL MASK
• 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: 17140923
• Report Number: 9616096-2023-00040
• Device Sequence Number: 11245707
• Product Code: MSH
• UDI-Device Identifier: 20680651467274
• UDI-Public: 20680651467274
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 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: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: AM8094841
• 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: 10/04/2022
• Initial Report FDA Received Date: 06/16/2023
• 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