MAUDE Adverse Event Report: O&M Halyard, Inc. HALYARD Absorbent Tray Liner; Sterilization Products

Model Number	48139
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2026
Type of Reportable Event	Malfunction

• Brand Name: HALYARD Absorbent Tray Liner
• Common Device Name: Sterilization Products
• Manufacturer (Section D): O&M Halyard, Inc.; 1220 old alpharetta road; suite 320; alpharetta GA 30005
• Manufacturer (Section G): La Ada De Acuna, S. De. R. L. De C. V.; av. hidalgo no. 6 esq; blvd. luis donaldo colosio; col.educativa, nogales sonora 84093
• Manufacturer Contact: angela bunn ; 1220 old alpharetta rd; suite 320; alpharetta, GA 30005 ; +1(770)401-1697
• MDR Report Key: 50351744
• Report Number: 3005997949-2026-00010
• Device Sequence Number: 12268142
• Product Code: PUI
• UDI-Device Identifier: 20680651481393
• UDI-Public: 20680651481393
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: Exempt
• 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,Followup
• Report Date (Section B): 09/22/2026

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: 48139
• Device Catalogue Number: 48139
• Device Lot Number: AC26132132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/28/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/23/2026
• 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