MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-ANGIO/CATH PACK-LF

Catalog Number	DYNJ19491L
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that on (b)(6) 2025, a provided "tapped on the three-way and the syringe cracked causing both contrast and blood to spray across the procedural suite into our anesthesia providers eyes." the customer stated that the anesthesia provider's eyes were "flushed" for "15 minutes" and was taken to the "emergency department where blood was drawn." the customer said the procedure was able to be completed.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 (b)(4) 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.
Event or Problem Description
It was reported that on (b)(6) 2025, a provided "tapped on the three-way and the syringe cracked causing both contrast and blood to spray across the procedural suite into our anesthesia providers eyes." the customer stated that the anesthesia provider's eyes were "flushed" for "15 minutes" and was taken to the "emergency department where blood was drawn.".

• Common Device Name: DBD-ANGIO/CATH PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: jessica walter ; three lakes drive; northfield, IL 60093
• MDR Report Key: 23693060
• Report Number: 1423395-2025-00196
• Device Sequence Number: 21135056
• Product Code: OES
• UDI-Device Identifier: 10198459077548
• UDI-Public: 10198459077548
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 12/02/2025

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: DYNJ19491L
• Device Lot Number: 25HMB677
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/06/2025
• 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