MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TTL1LYR 16FR10ML 100%SILI DB TRA

Model Number URO170716

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that the urinary catheter came out of the patient with the balloon still inflated.Reportedly, the balloon was inflated with 10ml of fluid.It is unknown how long after urinary catheter insertion the incident occurred.The patient was noted to have a urethral tear and required suture repair.A new urinary catheter was also required to be inserted.No additional patient impact, medical intervention, or follow-up care was reported to the manufacturer.No product problem/issue was reported to the manufacturer.No sample is available to be returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined at this time.Due to the reported need for medical intervention, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the urinary catheter came out of the patient with the balloon still inflated.

• Brand Name: MEDLINE
• Type of Device: TTL1LYR 16FR10ML 100%SILI DB TRA
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11744453
• MDR Text Key: 247947391
• Report Number: 1417592-2021-00075
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866911
• UDI-Public: 10888277866911
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: URO170716
• Device Catalogue Number: URO170716
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/21/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention