MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF

Catalog Number	DYND11532
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/31/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer reported that they were experiencing constant clogging of 100% silicone foley catheters, even after inserting new products and after irrigation.Due to the reported problem/issue, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
Clogging of catheter.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,16FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18784207
• Report Number: 1417592-2024-00114
• Device Sequence Number: 8333480
• Product Code: EZL
• UDI-Device Identifier: 40080196170983
• UDI-Public: 40080196170983
• 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): 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND11532
• Device Lot Number: 59223030318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Initial Report FDA Received Date: 02/26/2024
• 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