MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-CATH LAB PACK-LF

Catalog Number	DYNJ67851B
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, "some of our cath packs have had defective syringes in them.They look either smashed or melted." per the facility, "no patient was harmed.".
Additional Manufacturer Narrative
According to the facility, "some of our cath packs have had defective syringes in them.They look either smashed or melted." per the facility, "no patient was harmed." 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 (b)(4) 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.

• Common Device Name: DBD-CATH LAB PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield IL 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield, IL 60093
• MDR Report Key: 22679433
• Report Number: 1423395-2025-00079
• Device Sequence Number: 21067172
• Product Code: LRO
• UDI-Device Identifier: 10195327353056
• UDI-Public: 10195327353056
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 07/31/2025

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: DYNJ67851B
• Device Lot Number: 25DMH932
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/23/2025
• 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