MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; ANGIO TRAY NTX

Catalog Number	DYNJ68752B
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	09/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility on (b)(6) 2025 "while the physician was injecting the contrast, the back of the syringe plunger broke off and ended up piercing through the physician's glove and breaking the skin of his right palm".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2025 "while the physician was injecting the contrast, the back of the syringe plunger broke off and ended up piercing through the physician's glove and breaking the skin of his right palm".Per the facility "physician had to don gloves/sterile attire to wash his hands with soap and water, band aid applied to physician's palm before scrubbing back in to complete the procedure".The sample has been requested for evaluation.No additional information is available at this time.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.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.
Additional Manufacturer Narrative
Updated: b4,d9, g3, g6, h2, h3, h6.

• Common Device Name: ANGIO TRAY NTX
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23278682
• Report Number: 1423395-2025-00167
• Device Sequence Number: 8726416
• Product Code: OES
• UDI-Device Identifier: 10195327340995
• UDI-Public: 10195327340995
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 11/10/2025

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: DYNJ68752B
• Device Lot Number: 25GBC965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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