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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 surgery department at community hospital reported an issue involving halyard absorbent tray liners leaving debris inside instrument kits after processing through the sterile processing department (spd).The debris was discovered at the start of a surgical case, resulting in the procedure¿s cancellation.Additional information has been requested but not received.
Additional Manufacturer Narrative
The device history record (dhr) for the referenced lot was reviewed.All manufacturing and quality specifications were met prior to release, and no rework or special conditions were documented.A process review was conducted to assess potential lint-generation sources at the manufacturing line; no issues were identified.Visual inspections are performed per the control plan, and any product exhibiting foreign material is rejected.Controls to maintain environmental conditions related to foreign material include non-viable particle monitoring, and routine cleaning.Monitoring results for this lot were within defined limits and specifications.In addition, a preventive maintenance program is in place for the huck towel equipment, which includes regular cleaning of the machine.No changes in raw materials have been reported by suppliers that could contribute to increased lint formation.Manufacturing personnel were notified to increase awareness and reinforce the importance of delivering product free of foreign material.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.

• 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: 23493268
• Report Number: 3005997949-2025-00012
• Device Sequence Number: 12989483
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

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: AC25203032
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 11/28/2025
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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