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

Catalog Number DYND150816TS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/14/2024

Event Type  malfunction  

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 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".

• Type of Device: 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
• MDR Text Key: 337688292
• Report Number: 1417592-2024-00393
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 40195327149872
• UDI-Public: 40195327149872
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other