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 Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product involved in the event was returned for evaluation.Sample evaluation is in progress.A follow-up report will be provided upon conclusion of 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 an o&m halyard, inc.Product is defective or has caused serious injury.
Event or Problem Description
The tray liner exhibits brown stains.The customer stated this has resulted in delays up to (6) hours and multiple cancellations of cases.No instruments from the trays were used on patients.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
One (1) used sample was received with no product packaging.The sample was evaluated under ambient light conditions.The sample was laid out on the lab table.There are yellowish stains observed along the length of the sample along one of the folds.There are more yellowish stains observed in and around the same area.A representative section was viewed under magnification.The yellowish stains appear embedded into the fibers of the sample.The complaint details were forwarded to the appropriate functional area for investigation and root cause determination.A root cause could not be determined for the issue reported.The device history record of the lot number reported was reviewed and the product was found to be manufactured according to specifications.Manufacturing personnel were notified of complaint.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 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.; 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, mexico 84093 ; MX 84093
• Manufacturer Contact: nichole early ; 1 edison drive; alpharetta, GA 30005 ; 8287820529
• MDR Report Key: 19297124
• Report Number: 3005997949-2024-00005
• Device Sequence Number: 14956412
• Product Code: PUI
• UDI-Device Identifier: 30680651481390
• UDI-Public: 30680651481390
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 06/03/2024

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: AC24042184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2024
• 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: 04/15/2024
• Supplement Date Received by Manufacturer: 05/03/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/03/2024
• 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