MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TTL1LYR 16FR10ML 100%SIL TMP TRAY

Catalog Number	URO170816T
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	05/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility "the catheter would not drain past the connection where the actual catheter meets the tubing".Per the facility "staff irrigated and manipulated the tubing multiple times to try to get the foley to drain for 10-15 minutes".Per the facility they were eventually able to get the foley to drain.Per the facility the foley catheter was replaced and there was a reported infection related to the catheter where "draining/air locking was an issue".The sample was returned for evaluation and a dimensional analysis of the catheter found no issues or abnormalities.The investigation showed the blockage occurred due to blood clotting and encrustation of the catheter tip and eyelets no additional information is available at this time.It has been determined that the reported event caused or contributed to serious injury requiring medical intervention, 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 facility "the catheter would not drain past the connection where the actual catheter meets the tubing".

• Common Device Name: TTL1LYR 16FR10ML 100%SIL TMP TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes dr; northfield, IL 60093
• MDR Report Key: 19547308
• Report Number: 1417592-2024-00659
• Device Sequence Number: 6716197
• Product Code: OHR
• UDI-Device Identifier: 40888277866943
• UDI-Public: 40888277866943
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/17/2024

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: URO170816T
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2024
• Initial Report FDA Received Date: 06/17/2024
• 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