MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ANGIOGRAPHY DRAPE PACK

Catalog Number	DYNJ66529B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a syringe broke "about a month ago." no additional details are available related to the customer reported issue.
Additional Manufacturer Narrative
It was reported that a syringe broke "about a month ago." no additional details are available related to the customer reported issue.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.

• Brand Name: MEDLINE
• Common Device Name: ANGIOGRAPHY DRAPE PACK
• 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: 24055307
• Report Number: 1423395-2026-00006
• Device Sequence Number: 13188499
• Product Code: LRO
• UDI-Device Identifier: 10198459472831
• UDI-Public: 10198459472831
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 01/13/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYNJ66529B
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown