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

Model Number	DYND11519
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that a patient had a catheter in place for chronic urinary retention and after only two days the catheter came out on its own after the balloon popped.According to the nurse there was no external force placed on the catheter due to the device being secured with a securement device and a leg strap.The nurse stated that the patient contacted the home health nurse and a new catheter was placed without further incident.The patient is reportedly doing well at this time.The sample was not returned to the manufacturer 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
It was reported that a patient had a catheter in place for two days and the catheter came out on its own after the balloon popped.The catheter was replaced with a new catheter.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11371969
• Report Number: 1417592-2021-00024
• Device Sequence Number: 14391234
• Product Code: EZL
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/24/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11519
• Device Catalogue Number: DYND11519H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Weight: 79