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

Model Number	48139-01
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product involved in the event was returned for evaluation.A follow up report will be provided upon conclusion of investigation.Three (3) used samples were received.The samples were evaluated under ambient light conditions.The samples arrived rolled into bundles and stacked together.Each sample exhibits yellowish stains along the folds and also in areas where there are indentations.The indentations are possibly where objects with rounded edges or instruments were in contact with the tray liners.Representative areas of the yellowish stains were viewed under magnification.The appearance is that the fibers are stained with a yellowish substance.A device history record review has been conducted.No nonconformances were documented during the lot production.No contributing issues were noted.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.
Event or Problem Description
Brown spots were reported on the tray liners post customer sterilization of surgical trays.The site reported there was a delay in surgery (varying) and some cases had to be cancelled as a result.
Additional Manufacturer Narrative
The samples were evaluated under ambient light conditions.Each sample exhibits yellowish stains along the folds and also in areas where there are indentations.The indentations are possibly where objects with rounded edges or instruments were in contact with the tray liners.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.A device history record evaluation was performed for the lot number, the records indicate the product was manufactured according to approved manufacturing procedures and specifications and met all criteria for product final release.A root cause could not be determined for the issue reported.Manufacturing personnel were notified of this incident for awareness.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.

• Common Device Name: STERILIZATION PRODUCTS
• Manufacturer (Section D): O&M HALYARD, INC.; 1 edison drive; 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 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19405169
• Report Number: 3005997949-2024-00006
• Device Sequence Number: 6786710
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• 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): 06/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 48139-01
• Device Catalogue Number: 104813901
• Device Lot Number: AC24090063
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2024
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/07/2024
• Initial Report FDA Received Date: 05/28/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown