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

Model Number	URO170816S
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the catheter balloon ruptured and the catheter slid out.It was replaced with another catheter.The reported incident stated that while prepping for a nephrectomy on a female patient, the 16' french catheter balloon ruptured and the catheter slid out of the patient.Reportedly, another catheter was inserted without difficulty.Despite multiple good faith efforts to obtain additional information, no further patient details regarding this incident was provided.Due to the reported need to replace the foley catheter, this is an mdr reportable event.No sample was returned for evaluation.A root cause for the reported incident was unable to be determined.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported the catheter balloon ruptured and the catheter slid out.It was replaced with another catheter.

• Brand Name: Medline
• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10063406
• Report Number: 1417592-2020-00051
• Device Sequence Number: 17114206
• Product Code: EZL
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: URO170816S
• Device Catalogue Number: URO170816S
• Device Lot Number: 20ABJ819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention