MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SIL TMPST TR

Catalog Number	URO170816TS
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, 'a foley catheter was placed into the patient's bladder and the foley advanced all the way to the hub with good urine return'.When the balloon was inflated with the 'normal amount of sterile water the balloon burst and the foley came out'.
Additional Manufacturer Narrative
According to the customer, 'a foley catheter was placed into the patient's bladder and the foley advanced all the way to the hub with good urine return'.When the balloon was inflated with the 'normal amount of sterile water the balloon burst and the foley came out'.A second catheter was inserted due to the previous device dislodging.The sample is reported to be available but has not been returned for evaluation.No additional information is available at this time.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.

• Common Device Name: TTL1LYR 16FR10ML 100%SIL TMPST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15596221
• Report Number: 1417592-2022-00191
• Device Sequence Number: 2314898
• Product Code: OHR
• UDI-Device Identifier: 10889942127955
• UDI-Public: 10889942127955
• Combination Product (Y/N): N
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/13/2022

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: URO170816TS
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/22/2022
• Initial Report FDA Received Date: 10/13/2022
• 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 Sex: Unknown