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

Model Number	URO170816S
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was report, "the balloon popped after insertion as it was being inflated." a second foley catheter was then tested and it too burst before it was fully inflated.Due diligence has been completed.No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.Sample available and sent for evaluation.Investigation conclusion / root cause: "the reported issue of a burst foley catheter was confirmed through visual inspection of one (1, ea) used opened sample provided.Based on the condition of the product and the description of the issue, some possible root causes could be, but are not limited to, patient anatomy, insertion distance, physical damage on the catheter, etc.The manufacturing facility will be notified regarding the issue." if any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was report "the balloon popped after insertion as it was being inflated." a second foley catheter was then tested and it too burst before it was fully inflated.

• Brand Name: MEDLINE
• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11556531
• Report Number: 1417592-2021-00036
• Device Sequence Number: 3433547
• Product Code: OHR
• UDI-Device Identifier: 10889942126828
• UDI-Public: 10889942126828
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/23/2021

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: 20GBD790
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/23/2021
• 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