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

Model Number	DYND11504
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Perforation (2205)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
According to the customer on 01/17/23 "the foley catheter came out as the balloon was no longer inflated".

• Brand Name: Medline
• Common Device Name: 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
• Report Number: 1417592-2023-00050
• Device Sequence Number: 6221044
• Product Code: EZL
• UDI-Device Identifier: 10080196845521
• UDI-Public: 10080196845521
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/09/2023

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: DYND11504
• Device Catalogue Number: DYND11504H
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 02/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown