MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP Medline; TTL1LYR 16FR10ML 100%SILI UMST TR

Model Number	URO170816S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that an inpatient with urinary retention had a urinary catheter inserted.The registered nurse reported the catheter became dislodged and another catheter was required to be inserted.According to the physician the original catheter was placed on (b)(6) 2022 in which 30ml's of fluid was used to inflate the balloon port without difficulty.On (b)(6) 2022 the registered nurse reported that his patient's catheter became dislodged and the balloon was deflated.The nurse flushed the balloon with fluid and the balloon would not inflate and fluid would leak out.Another catheter was required to be inserted.The patient is now stable.The sample was not 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 an inpatient with urinary retention had a urinary catheter inserted.The registered nurse reported the catheter became dislodged and another catheter was required to be inserted.

• Brand Name: Medline
• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• 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: 13592412
• Report Number: 1417592-2022-00017
• Device Sequence Number: 4753025
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 02/24/2022

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: URO170816S
• Device Catalogue Number: URO170816S
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2022
• Initial Report FDA Received Date: 02/24/2022
• 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 Age: 66 YR
• Patient Sex: Male