MAUDE Adverse Event Report: O&M HALYARD, INC. HALYARD ABSORBENT TRAY LINER; STERILIZATION PRODUCTS

Model Number	48139
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Incident two the product involved in this complaint is reported to be available for evaluation.A follow-up report will be provided upon conclusion of the investigation.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, in compliance with the medical device reporting requirement and should not be considered to be an admission that product is defective or has caused serious injury.
Event or Problem Description
The sterilization process appears to have activated adhesive and fiber fragments originating from the halyard absorbent tray liner.Adhesive and fibers were found on surgical instruments.No injury was reported.Two procedures (coronary artery bypass graft and spine) were canceled as result of discovery.
Additional Manufacturer Narrative
Incident two.A review of the device history record (dhr) and quality nonconformance (qnc) databases identified no abnormalities.The current manufacturing process was also evaluated, and no issues were reported during production of this product.The investigation relied on the information supplied by the customer, which included a single photograph sufficient to support the assessment.A review of internal processes did not identify any manufacturing-related root cause or potential sources of lint generation.Supplier specifications were also reviewed and confirm that the material may contain a natural level of lint inherent to its composition, which is acceptable within defined limits.No changes in raw materials have been reported by suppliers that would contribute to increased lint.Per specification, some lint presence is expected and allowable.Visual inspection is performed per the control plan (huck towel machine process control plan).Any foreign material identified during inspection is rejected per procedure.Manufacturing personnel were notified of the incident to reinforce awareness and emphasize the importance of preventing defective material from reaching finished goods.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, in compliance with the medical device reporting requirement 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: HALYARD ABSORBENT TRAY LINER
• Common Device Name: STERILIZATION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1220 old alpharetta rd.; ste 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
• Manufacturer Contact: nichole coggins ; 1220 old alpharetta rd.; ste 320; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 23480402
• Report Number: 3005997949-2025-00011
• Device Sequence Number: 18705235
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): Unknown
• 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): 12/08/2025

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: AC25255313 AC25100051-52
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/08/2025
• 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