MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; CATHETER,FOLEY,TEMP SENS,8FR 3ML,LF

Catalog Number DYND110508

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 02/09/2024

Event Type  Injury  

Event Description

According to the facility on (b)(6) 24 the temperature cord inside temp sensing foley found to be tangled and not straight after the temperature reading drastically changed.

Manufacturer Narrative

According to the facility on (b)(6) 24 the temperature cord inside temp sensing foley found to be tangled and not straight after the temperature reading drastically changed.Per the facility it also appeared to be poking through the plastic.Per the facility the foley catheter was replaced.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.

• Type of Device: CATHETER,FOLEY,TEMP SENS,8FR 3ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18902873
• MDR Text Key: 337647169
• Report Number: 1417592-2024-00386
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10884389122990
• UDI-Public: 10884389122990
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/14/2024

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: DYND110508
• Device Lot Number: 592230902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2024
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other