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

Catalog Number	DYNJ66529B
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	12/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a "syringe broke during a procedure causing blood to splash on the operator".The customer reported that the clinician was "clearing a syringe of patient's blood and it shattered and bloody fluid sprayed around including on my face and a few droplets in my eye." the customer stated that the syringe broke at "the main outer cylinder." the customer did not report any follow-up care for bloodborne exposure.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 a "syringe broke during a procedure causing blood to splash on the operator".The customer reported that the clinician was "clearing a syringe of patient's blood and it shattered and bloody fluid sprayed around including on my face and a few droplets in my eye." the customer stated that the syringe broke at "the main outer cylinder." the customer did not report any follow-up care for bloodborne exposure.

• Brand Name: MEDLINE
• Common Device Name: ANGIOGRAPHY DRAPE PACK
• 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: 24082066
• Report Number: 1423395-2026-00010
• Device Sequence Number: 5789630
• 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): 01/15/2026

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: DYNJ66529B
• Device Lot Number: 25IBS890
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2026
• Initial Report FDA Received Date: 01/15/2026
• 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