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

Catalog Number DYND11532

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  

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 Description

Clogging of catheter.

• Type of Device: 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
• MDR Text Key: 336263834
• Report Number: 1417592-2024-00114
• 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: DYND11532
• 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