MAUDE Adverse Event Report: O&M HALYARD, INC. FLUIDSHLD PROC MASK; FLUIDSHIELD* LEVEL 3 FOG-FREE PROCEDURE MASK

Model Number	47107
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
We have had reports of ear loops breaking on the 47107 masks 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 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.
Additional Manufacturer Narrative
One (1) unused sample received with no product packaging.There are two lot numbers reported in this complaint.Only one (1) sample was received.The sample was evaluated under lot number am0102111; however, it is not known if the sample belongs to this lot number.The sample was evaluated under ambient light conditions.The samples were found to be assembled according to the specification drawing.Observation: the right and left ear loop placement are slightly skewed; however, the ear loop material is securely bonded to the mask.The ear loops were given a moderate tug while being inspected.The ear loops did not detach.The device history records (dhr) evaluation was performed for product code 47107 as identified in the complaint.According to the documented records, the product was manufactured according to the approved manufacturing procedures and specifications then released by quality assurance.A quality nonconformance was not reported at the time of production.Manufacturing conducts visual and functional inspections throughout production.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, 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: FLUIDSHLD PROC MASK
• Common Device Name: FLUIDSHIELD* LEVEL 3 FOG-FREE PROCEDURE 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: 17435592
• Report Number: 9616096-2023-00081
• Device Sequence Number: 6779929
• Product Code: FXX
• UDI-Device Identifier: 30680651471070
• UDI-Public: 30680651471070
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K111402
• 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): 08/01/2023

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: 47107
• Device Catalogue Number: 991047107
• Device Lot Number: AM0102111
• 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: 05/29/2020
• Initial Report FDA Received Date: 08/01/2023
• 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