MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PK,RADIOLOGY-PORTSMOUTH

Catalog Number	DYNJ44087B
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, during a diagnostic angiogram, the doctor used a 10 cc syringe to draw back blood into a contrast-filled syringe and then pushed forward as part of the standard process, and the 10 cc syringes cracked under normal pressure, causing a considerable amount of bloodborne pathogens to splatter staff and equipment.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
According to the facility on (b)(6) 2026, during a diagnostic angiogram, the doctor used a 10 cc syringe to draw back blood into a contrast-filled syringe and then pushed forward as part of the standard process, and the 10 cc syringes cracked under normal pressure, causing a considerable amount of bloodborne pathogens to splatter staff and equipment.

• Brand Name: MEDLINE
• Common Device Name: PK,RADIOLOGY-PORTSMOUTH
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24433668
• Report Number: 1423395-2026-00027
• Device Sequence Number: 16009418
• Product Code: OEZ
• UDI-Device Identifier: 10195327346584
• UDI-Public: 10195327346584
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2026

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: DYNJ44087B
• Device Lot Number: 25IBS887
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/26/2025
• 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