MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP MEDLINE; PLUG,CATHETER,DRAINAGE PROTECTOR,TUBE

Catalog Number	DYND12200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per email, doctor was trying to use the cap during a case requiring chemo medication to be inserted into the bladder.After the medication was placed in the patient, the doctor expressed to me that he had quite a lot of difficulty attempting to put the cap in the foley catheter.He said that chemo medication was leaking around the cap also.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Event or Problem Description
Per email, doctor was trying to use the cap during a case requiring chemo medication to be inserted into the bladder.After the medication was placed in the patient, the doctor expressed to me that he had quite a lot of difficulty attempting to put the cap in the foley catheter.He said that chemo medication was leaking around the cap also.

• Brand Name: MEDLINE
• Common Device Name: PLUG,CATHETER,DRAINAGE PROTECTOR,TUBE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: brooke jantzen ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 25116642
• Report Number: 1417592-2026-01023
• Device Sequence Number: 21390280
• Product Code: KGZ
• UDI-Device Identifier: 10080196030873
• UDI-Public: 10080196030873
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: DYND12200
• Device Lot Number: 96925010001
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/01/2025
• 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