MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER FOLEY 2W 100% SILI 10CC 14FR

Catalog Number DYND11501

Device Problem Obstruction of Flow (2423)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/31/2024

Event Type  Injury  

Event Description

Clogging of catheter.

Manufacturer Narrative

The customer reported that they were experiencing constant clogging of 100% silicone foley catheters, even after inserting new products and after irrigation.No additional information was provided despite attempts to obtain.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional information becomes available this report will be reopened and reevaluated.

• Type of Device: CATHETER FOLEY 2W 100% SILI 10CC 14FR
• 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: 18777387
• MDR Text Key: 336201729
• Report Number: 1417592-2024-00111
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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: DYND11501
• Device Lot Number: 59223030318
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2024
• Initial Date FDA Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other