MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; NON-VASCULAR PACK

Catalog Number	DYNJ56386D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	02/02/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that on (b)(6) 2026 the surgeon "got a significant cut in his palm hand while performing a cerebral angio" when a "green syringe 10cc from the ir non vascular pack" broke during use.
Additional Manufacturer Narrative
It was reported that on (b)(6) /2026 the surgeon "got a significant cut in his palm hand while performing a cerebral angio" when a "green syringe 10cc from the ir non vascular pack" broke during use.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.In an abundance of caution, and in response to an fda 483 issued for cfn 1417592 on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

• Brand Name: MEDLINE
• Common Device Name: NON-VASCULAR PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield, il 60093 2753; MX 600932753
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24505894
• Report Number: 1423395-2026-00036
• Device Sequence Number: 10415955
• Product Code: LRO
• UDI-Device Identifier: 10198459123382
• UDI-Public: 10198459123382
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213481
• 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): 03/04/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ56386D
• Device Lot Number: 25IBE172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/04/2025
• 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: Male