MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TTLVENT 16FR10ML 100%SIL DB TR

Model Number	URO180716
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the patient had a 16fr foley catheter placed around (b)(6) 2021.The catheter was clamped and the tubing was disconnected from the catheter.Once the system was disconnected the clamp was then removed and placed on the inflation/deflation valve tubing.The clinician then began to push 60cc of contrast without any pressure/resistance.Reportedly the patient stated that the catheter ruptured and the clinician stopped the procedure.The system was reconnected and contrast and blood was observed in the bag.The catheter was removed from the patient and a tear was noted in the balloon.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No samples have been returned for evaluation.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that during an imaging procedure the foley catheter balloon ruptured while inserted in the patient while the balloon was being filled.The procedure was stopped and the system was reconnected to the bag.Contrast and blood was observed in the bag.No additional information is available.

• Brand Name: Medline
• Common Device Name: TTLVENT 16FR10ML 100%SIL DB TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 12915947
• Report Number: 1417592-2021-00214
• Device Sequence Number: 5588502
• Product Code: OHR
• UDI-Device Identifier: 10889942687084
• UDI-Public: 10889942687084
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/02/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: URO180716
• Device Catalogue Number: URO180716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Initial Report FDA Received Date: 12/02/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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