MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP TTL1LYR 16FR10ML 100%SILI UM TRAY

Model Number	URO170816
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the patient was using the catheter for a chronic condition and the current catheter was placed on (b)(6) 2022.The patient was reported to have dementia and pulled out the catheter with the balloon inflated one week later which resulted in the balloon shredding.The facility evaluated the patient and the catheter and determined that there was no serious injury that occurred or follow up care that was needed.A new catheter was placed without incident.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
It was reported that the patient pulled out the foley catheter with the balloon inflated which resulted in the balloon shredding.A new catheter was placed without incident.

• Brand Name: TTL1LYR 16FR10ML 100%SILI UM TRAY
• Common Device Name: TTL1LYR 16FR10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 16417946
• Report Number: 1417592-2022-00118
• Device Sequence Number: 5632306
• Product Code: OHR
• UDI-Device Identifier: 10888277862623
• UDI-Public: 10888277862623
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/29/2022

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: URO170816
• Device Catalogue Number: URO170816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2022
• Initial Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female