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

Model Number	48139-01
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in this complaint is not 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
Brown stains were found on tray liner and instrument.Implants had been placed on the liner for procedure at time of discovery of the foreign material.Procedure was initially delayed an hour and half as a result, then rescheduled.The back table was considered sterility compromised upon discovery of the stains.Implants were scrubbed and resterilized for the next case.Patient was under anesthesia at the time of discovery, there were no other known patient affects per complaint reporter.
Additional Manufacturer Narrative
The assessment of the device history record cannot be conducted due to the absence of the lot number and sample.As mentioned in the description, the stains emerged following the sterilization of the instruments.Factors that need to be taken into account include the sterilization methods and the chemicals or substances utilized during the process.Given that absorption is a significant characteristic, the fabric can become embedded with various substances; and depending on factors such as temperature, chemical interactions, and stain pigmentation, the appearance of stains may differ.Occasionally, brown staining of tray liner fabric has been noted following steam sterilization.Analytical testing was deemed the most suitable approach to assess the stains.In previous complaint instances, some samples were dispatched to an independent laboratory for analysis.The compositional components of halyard* tray liners include carbon and oxygen.The analysis of the brown stains revealed the presence of eleven naturally occurring elements.An internal review of chemical hazards was performed on each element by o&m halyard product safety, which concluded that there were no safety issues.No definitive root cause has been identified.This product incident is documented in the o&m halyard, inc.Complaint database and identified as complaint comp (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.

• 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: 22478521
• Report Number: 3005997949-2025-00005
• Device Sequence Number: 15499969
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/29/2025

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: 48139-01
• Device Catalogue Number: 104813901
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 07/29/2025
• 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