MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; DYND11504H

Model Number DYND11504

Device Problems Material Puncture/Hole (1504); Material Perforation (2205)

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

Event Date 01/17/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer on 01/17/23 "the foley catheter came out as the balloon was no longer inflated".Per the customer "upon inspection we inserted the syringe to put the saline solution in to see that it was squirting right back out".Per the customer they then inserted a new catheter.The customer stated they used 10cc's to inflate the balloon and upon insertion the catheter "appeared to be normal".Per the customer the individual is reporting to be doing "ok".No additional information is available at this time.The sample has been requested, but has not been returned for evaluation.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 01/17/23 "the foley catheter came out as the balloon was no longer inflated".

• Brand Name: Medline
• Type of Device: DYND11504H
• 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: 16334968
• MDR Text Key: 309148464
• Report Number: 1417592-2023-00050
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196845521
• UDI-Public: 10080196845521
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: DYND11504
• Device Catalogue Number: DYND11504H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/23/2023
• 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