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

Catalog Number	URO170816S
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	02/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 the "sampling port on the foley catheter broke while attempting to obtain urine sample with syringe".The customer reported the catheter was removed and a new catheter was inserted.The customer reported the new catheter sample port "detached completely from the catheter, which created an opening in the catheter tubing" when removing a syringe from the port on (b)(6) 2024.The customer reported they are unable to confirm if an additional foley was placed after the second port breakage.The customer reported the patient now has a "bloodstream infection secondary to cauti".No additional information is available.It has been determined that the reported event caused or contributed to serious injury, therefore, 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, the "sampling port on the foley catheter broke while attempting to obtain urine sample with syringe", a new catheter was inserted, and the new catheter sample port "detached completely from the catheter, which created an opening in the catheter tubing" when removing a syringe from the port.
Additional Manufacturer Narrative
Update to d9- is this device available for evaluation? update to h3- device evaluated by manufacturer? update to h6- type of investigation.

• Common Device Name: TTL1LYR 16FR10ML 100%SILI UMST TR
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19004228
• Report Number: 1417592-2024-00448
• Device Sequence Number: 18254262
• Product Code: OHR
• UDI-Device Identifier: 40889942126829
• UDI-Public: 40889942126829
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

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: URO170816S
• Device Lot Number: 23IBN648
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/15/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 04/29/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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