MAUDE Adverse Event Report: MEDLINE INDUSTRUIES LP Medline; TTL1LYR 16FR10ML 100%SIL TMP TRAY

Model Number URO170816T

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that a patient was being transferred from the emergency department to the trauma and burn intensive care unit (tbicu).A catheter was inserted in the emergency department with ease with no issues noted inflating the balloon.Urine drainage was confirmed and the patient received a cystogram.Reportedly a few hours after the catheter was placed, upon arrival to tbicu, the catheter was noted to be dislodged and the balloon was no longer inflated.There was no reported trauma or injury to the patient.A new catheter was successfully inserted.The actual sample was disposed of and is not available to be returned for evaluation.There is no additional information available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that a few hours after the catheter was placed, the catheter was noted to be dislodged and the balloon was no longer inflated.A new catheter was successfully inserted.No additional information is available.

• Brand Name: Medline
• Type of Device: TTL1LYR 16FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRUIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12771702
• MDR Text Key: 283409037
• Report Number: 1417592-2021-00201
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866942
• UDI-Public: 10888277866942
• 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: 11/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URO170816T
• Device Catalogue Number: URO170816T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/28/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention