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

Model Number	46827
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
A nurse who was in a covid positive room at (b)(6) university was wearing one of halyard's n95 masks when the strap broke.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
A total of sixteen (16) samples were received in the following grouping: thirteen (13) kimberly clark branded masks, two (2) o&m halyard, inc.Branded masks, one (1) halyard health inc.Branded mask and one (1) empty kimberly clark product box for lot number a j608317c was received.The samples were evaluated under ambient light conditions.The thirteen (13) kimberly clark branded samples were laid out on the lab table.The blue elastic head bands appear stuck together and wavy.Six (6) of these samples were inspected more closely.The elastic headbands were given a tug as if for donning.The headbands on one sample detached from the corner bond.The elastic of all the samples did not retract.One (1) halyard health, inc.Branded sample arrived with the left (as worn) elastic completely detached from the corner bond.The elastic does not appear to be damaged at the bond area.There is no residual elastic inside the bond area of the left side.The headbands appear securely attached to the right side corner bond area.Two (2) o&m halyard, inc.Samples were inspected.The elastic head bands were given a tug as if for donning.No detachment occurred on either sample.The elastic remained securely attached to the inside of the corner bond areas.This product is over 14 years old from the lot provided.Code 46827 mentioned in complaint has a shelf life of 5 years.Therefore this product has expired.A potential root cause is product had expired and there is material degradation as a result.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 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: 17076067
• Report Number: 9616096-2023-00028
• Device Sequence Number: 6775748
• Product Code: MSH
• UDI-Device Identifier: 30680651468278
• UDI-Public: 30680651468278
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 06/06/2023

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: J608317C
• 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: 08/27/2020
• Initial Report FDA Received Date: 06/06/2023
• 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