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

Catalog Number	DYNJ42167F
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, the "10ml syringes are coming in cracked." 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, the "10ml syringes are coming in cracked.".

• Common Device Name: ANGIOGRAPHY DRAPE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield 60093
• MDR Report Key: 22998319
• Report Number: 1423395-2025-00117
• Device Sequence Number: 18521447
• Product Code: LRO
• UDI-Device Identifier: 10198459038600
• UDI-Public: 10198459038600
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 09/08/2025

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
• Device Catalogue Number: DYNJ42167F
• Device Lot Number: 25CBB169
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/03/2025
• 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
• Patient Sex: Unknown