MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TTL1LYR 16FR10ML 100%SILI UM TRAY

Catalog Number	URO170816
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer on 1/3/2024, the foley catheter "came out of the urethra" after inflation.After this, the customer stated upon attempting to inflate the ballon again, the balloon "would not inflate".The customer stated that "a new foley kit was acquired and inserted with no issue" and that the patient had "no issues related to malfunction".No additional information is available.The sample was requested 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 1/3/2024, the foley catheter "came out of the urethra" after inflation.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL
• MDR Report Key: 18580549
• Report Number: 1417592-2024-00037
• Device Sequence Number: 8246529
• Product Code: OHR
• UDI-Device Identifier: 10888277862623
• UDI-Public: 10888277862623
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 01/25/2024

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: URO170816
• Device Lot Number: 23KBF676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Initial Report FDA Received Date: 01/25/2024
• 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: Other
• Patient Sex: Unknown