MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

Model Number DYND11519

Device Problem Leak/Splash (1354)

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

Event Date 02/20/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer on (b)(6) 2023 there was "leakage from around the tubing" of the foley catheter after being in place for a day.The customer reported a new catheter was placed.There was no injury reported due to the incident.No additional information is available at this time.The sample was not returned for evaluation at this.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer on (b)(6) 2023 there was "leakage from around the tubing" of the foley catheter after being in place for a day.The customer reported a new catheter was placed.

• Brand Name: Medline
• Type of Device: TRAY,FOLEY,100% SILICONE,16FR,10ML,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: 16627442
• MDR Text Key: 312120609
• Report Number: 1417592-2023-00143
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• 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: 03/28/2023

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 Model Number: DYND11519
• Device Catalogue Number: DYND11519
• Device Lot Number: 9692260001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/06/2023
• Initial Date FDA Received: 03/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other