MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATH LAB & E. P. PACK

Catalog Number	DYNJ64626B
Medical Device Problem Codes	Defective Component (2292); Manufacturing, Packaging or Shipping Problem (2975)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the facility, "for the 10ml syringes in this pack, there is an issue with the plunger being defective and breaking." 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, "for the 10ml syringes in this pack, there is an issue with the plunger being defective and breaking.".

• Common Device Name: CATH LAB & E. P. PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield 60093
• MDR Report Key: 22936969
• Report Number: 1423395-2025-00100
• Device Sequence Number: 9893142
• Product Code: OES
• UDI-Device Identifier: 10195327196196
• UDI-Public: 10195327196196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 09/01/2025

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: DYNJ64626B
• Device Lot Number: 25DBG678
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Initial Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2025
• 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