MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; ADAPTER,CATHETER/SYRINGE/LUER,STERILE

Catalog Number	DYND2219
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the customer, "the blue catheter adapter does not adequately fit into the foley catheter lumen, resulting in leakage around the connection between the catheter and the adapter.The medication was reported to leak out around the adapter connection".
Additional Manufacturer Narrative
According to the customer, "the blue catheter adapter does not adequately fit into the foley catheter lumen, resulting in leakage around the connection between the catheter and the adapter.The medication was reported to leak out around the adapter connection".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: ADAPTER,CATHETER/SYRINGE/LUER,STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: sabrina surmaj ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24308525
• Report Number: 1417592-2026-00100
• Device Sequence Number: 13168386
• Product Code: GCD
• UDI-Device Identifier: 10884389123430
• UDI-Public: 10884389123430
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 02/10/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: DYND2219
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2025
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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