MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 6FR3ML100%SILTMP UM SL

Catalog Number	UROT1105
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on (b)(6), the balloon did not inflate for a neonate so the foley was immediately removed.The foley was unable to inflate after removal.A new foley was placed.The rn tested the balloon and it was hard to inflate but did inflate with increased pressure.This was placed without issue on the patient.The customer reported that there was no serious injury and that a sample is available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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 customer, on (b)(6), the balloon did not inflate for a neonate so the foley was immediately removed.

• Common Device Name: TTL1LYR 6FR3ML100%SILTMP UM SL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20665534
• Report Number: 1417592-2024-00955
• Device Sequence Number: 12588968
• Product Code: OHR
• UDI-Device Identifier: 40195327101269
• UDI-Public: 40195327101269
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 11/12/2024

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
• Device Catalogue Number: UROT1105
• Device Lot Number: 24EBG534
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2024
• Initial Report FDA Received Date: 11/12/2024
• 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: Other
• Patient Sex: Unknown
• Patient Weight: 3 KG