MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,SKIN SCRUB,DRY,W/GAUZE

Catalog Number	DYND70664
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2023 during an "ent procedure", the gauze was used to apply "hibiclens" to the incision site "prior to the incision being made" and the "gauzed frayed".The customer reported they tried "to remove the fibers from the skin before making the incision".The customer reported a "possibility of retained fragments if they were not all removed by the surgeon and surgical team" but, they were unable to confirm if the gauze fragments were left in the incision.The customer reported they are unable to determine if there were any negative outcomes for the patient related to the reported incident.The customer did not report any serious injury, medical intervention, or follow up care related to the reported incident.No additional information is available at this time.Sample requested for return evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the customer, on (b)(6) 2023 during an "ent procedure", the gauze was used to apply "hibiclens" to the incision site "prior to the incision being made" and the "gauzed frayed".

• Common Device Name: TRAY,SKIN SCRUB,DRY,W/GAUZE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18608717
• Report Number: 1417592-2024-00042
• Device Sequence Number: 9078106
• Product Code: OJU
• UDI-Device Identifier: 10080196813841
• UDI-Public: 10080196813841
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/30/2024

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 Catalogue Number: DYND70664
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/02/2024
• Initial Report FDA Received Date: 01/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown