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

Model Number	46727
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Four (4) kimberly clark branded samples were received.One kimberly clark product box was received.The samples were evaluated under ambient light conditions.The samples were opened and inspected.Each of the samples elastic head bands appear stuck together.The elastics feel stiff and brittle.The elastic of one sample was tugged as if for donning.The elastic broke in the center of the bands detaching a section of the elastic.This product is over 14 years old from the lot provided aj613116d.Code 46727 mentioned in complaint has a shelf life of 5 years.This product has expired.Notification was sent to manufacturing leaders for awareness.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
Incident two: "surgeon was wearing above product during surgical case.The straps on the n95 broke early in the case and the mask fell onto the sterile field contaminating the surgeon's right hand, the instrument in his hand and then fell onto the patient's drape.The surgeon had to stop his procedure, hand off contaminated instrument, change gloves, and cover the draped area with new drapes" 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: ICP FACIAL PROTECTION PRODUCTS
• Manufacturer (Section D): O&M HALYARD; 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: 17076247
• Report Number: 9616096-2023-00031
• Device Sequence Number: 17703230
• Product Code: MSH
• UDI-Device Identifier: 30680651467271
• UDI-Public: 30680651467271
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: Other Health Care Professional
• 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: 46727
• Device Catalogue Number: 991046727
• Device Lot Number: AJ613116D
• 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: 10/21/2020
• 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