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

Model Number URO170816S

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 01/27/2022

Event Type  malfunction  

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 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
• Type of Device: 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
• MDR Text Key: 296478971
• Report Number: 1417592-2022-00017
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• 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: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: URO170816S
• Device Catalogue Number: URO170816S
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 66 YR
• Patient Sex: Male