MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; TOWEL,OR,DSP,ST,BLUE,PREM,4/PK,20PK/CS

Catalog Number	MDT2168404
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Instrument snagged portion of stitching which caused instrument to puncture aorta.
Additional Manufacturer Narrative
It was reported that "during open heart procedure, instrument snagged portion of stitching which caused instrument to puncture aorta.Portion of seam came loose and separated from towel.2 surgeons spent time retrieving the seam." it was reported that the "patient is ok".It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Additional Manufacturer Narrative
Updated section h6 as it relates to the type of investigation, investigation findings/conclusions.

• Brand Name: MEDLINE
• Common Device Name: TOWEL,OR,DSP,ST,BLUE,PREM,4/PK,20PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nakiya graves ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24292851
• Report Number: 1417592-2026-00097
• Device Sequence Number: 13115511
• Product Code: FRL
• UDI-Device Identifier: 10193489008746
• UDI-Public: 10193489008746
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,Followup
• Report Date (Section B): 05/26/2026

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?: Yes
• Device Catalogue Number: MDT2168404
• Device Lot Number: 50525040030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2026
• Supplement Date Received by Manufacturer: 04/22/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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