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

Catalog Number	DYND150816TS
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Urinary Retention (2119)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on (b)(6) 2024 after an "open heart" procedure, the patient's foley was "not draining urine despite troubleshooting".
Additional Manufacturer Narrative
According to the customer, on (b)(6) 2024 after an "open heart" procedure, the patient's foley was "not draining urine despite troubleshooting".The customer reported the bladder scan indicated "475 ml of urine in bladder".The customer reported after the incident occurred the catheter was removed, and a new catheter was placed.The customer reported there was no patient harm as a result of the reported incident.The customer reported no serious injury or follow-up care needed related to the reported incident.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.

• Common Device Name: TRAY FOL TEMP UM 16FR 10ML MF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19081370
• Report Number: 1417592-2024-00483
• Device Sequence Number: 15360690
• 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): 04/10/2024

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: DYND150816TS
• Device Lot Number: 23KBT555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2024
• Initial Report FDA Received Date: 04/10/2024
• 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