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

Model Number	48139-01
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was returned for evaluation.One sample was received and evaluated under ambient light conditions.The sample arrived folded but not as in the original state.There is a handwritten note adhered to the folded sample with a lot number that matches the number reported.The sample was laid out on the table for inspection.There are three (3) white fibrous masses observed on both sides of the sheet.The fibrous masses appear entangled into the sheet.The fibrous masses measure approximately between 5mm and 4cm.The fibrous masses were viewed under magnification.The areas appear raised and thicker on the sheet.The sheet was shaken lightly on the table, no particulates were observed on the table.The finished product lot was released on 02/10/24, no quality nonconformances occurred during production.The product was found to meet all acceptance and final release criteria.Environmental monitoring results were reviewed during manufacturing and all conditions were found to be within acceptable limits.No prior supplier corrective action requests were issued for the raw material.There is no adverse trend for lint or static for the tray liner product.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 a o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The nursing team filed a complaint regarding white particles from the tray liner falling off into the instrumentation tray upon opening.The particles were reported to affect the surgical field sterility.Attempts were made to gather more information regarding incident impact on (b)(6) 2024.The customer has not responded.

• Brand Name: HALYARD ABSORBENT TRAY LINER
• Common Device Name: ABSORBENT TRAY LINER
• 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: 18895638
• Report Number: 3005997949-2024-00001
• Device Sequence Number: 6248266
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/13/2024

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: AC23313054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2024
• Initial Report FDA Received Date: 03/13/2024
• 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
• Patient Sex: Unknown