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

Model Number	DYND11519
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) 2022 a home health nurse was called to replace a medline foley catheter that was placed earlier that day, and would not drain.Per the facility the care giver flushed the catheter and noted that the catheter flushed easily.Per the facility the catheter then began to leak around the tubing, and the catheter was then removed and replaced with a new foley catheter.According to the facility the foley was noted to be draining well at the end of the visit.The sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and 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.
Event or Problem Description
According to the facility on (b)(6) 2022 a home health nurse was called to replace a medline foley catheter that was placed earlier that day, and would not drain.

• Brand Name: Medline
• Common Device Name: 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: 15404824
• Report Number: 1417592-2022-00160
• Device Sequence Number: 14997055
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 09/12/2022

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
• Operator of Device: Health Professional
• Device Model Number: DYND11519
• Device Catalogue Number: DYND11519H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/12/2022
• 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: Required Intervention
• Patient Sex: Female
• Patient Weight: 50 KG