MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; INTERVENTIONAL RADIOLOGY PACK

Catalog Number	DYNJT4956
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "the syringe plungers have sheared in half when doing an injection which is a safety risk." no additional details are available related to the customer reported issue.Despite good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.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.
Event or Problem Description
It was reported that "the syringe plungers have sheared in half when doing an injection which is a safety risk.".
Additional Manufacturer Narrative
Update to h6: investigation findings (c).

• Brand Name: MEDLINE
• Common Device Name: INTERVENTIONAL RADIOLOGY 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: 24344534
• Report Number: 1423395-2026-00022
• Device Sequence Number: 15911679
• Product Code: LRO
• UDI-Device Identifier: 10198459460142
• UDI-Public: 10198459460142
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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,Followup
• Report Date (Section B): 03/10/2026

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: DYNJT4956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2026
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/10/2026
• 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