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

Model Number DYND11519

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2021

Event Type  Injury  

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 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
• Type of Device: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11371969
• MDR Text Key: 233263203
• Report Number: 1417592-2021-00024
• Device Sequence Number: 1
• Product Code: EZL
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND11519
• Device Catalogue Number: DYND11519H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 79