MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY FOL TEMP UM 16FR 10ML MF

Catalog Number	DYND150816TS
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	02/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the customer on (b)(6) 2024, the "patient's urine output had drastically decreased overnight and early in the morning and the physician was notified".The customer reported that "the foley did not appear to be kinked.Despite attempts to reposition the patient and adjust the catheter tubing, there was no urine being drained".The customer stated that "attempts were made to manually irrigate the catheter to dislodge any obstructions, but this was unsuccessful in restoring proper drainage" and also stated "a bladder scan was done at this time, and the volume was noted to be significant at greater than 950ml therefore a decision was made to replace the foley catheter with a new one to ensure proper drainage, which was successful".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) 2024, the "patient's urine output had drastically decreased overnight and early in the morning and the physician was notified".

• Common Device Name: TRAY FOL TEMP UM 16FR 10ML MF
• 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: 18905945
• Report Number: 1417592-2024-00393
• Device Sequence Number: 20805097
• Product Code: OHR
• UDI-Device Identifier: 40195327149872
• UDI-Public: 40195327149872
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 03/14/2024

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: DYND150816TS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 03/14/2024
• 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