MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; 1LYR 14FR10ML 100%SIL TMP SAFE

Catalog Number	URO170814TQ
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	09/09/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on (b)(6) during a procedure a foley catheter was placed after the balloon was 'filled and seated'.Per the facility when the patient was being turned for the procedure the catheter slid out and an additional catheter needed to be placed.No additional information is available.The sample has been returned for evaluation but a root cause cannot be determined 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.
Event or Problem Description
According to the facility on 09/09 during a procedure a foley catheter was placed after the balloon was 'filled and seated'.Per the facility when the patient was being turned for the procedure the catheter slid out and an additional catheter needed to be placed.
Additional Manufacturer Narrative
Updated: b4,d2,d4,g6 supplemental medwatch filed to correct product info.

• Common Device Name: 1LYR 14FR10ML 100%SIL TMP SAFE
• 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: 15581751
• Report Number: 1417592-2022-00177
• Device Sequence Number: 20457716
• Product Code: OHR
• UDI-Device Identifier: 40193489723480
• UDI-Public: 40193489723480
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 11/08/2024

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: URO170814TQ
• Device Lot Number: 21IBT975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2022
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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