MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TTLVENT 16FR10ML 100%SIL UM TR

Model Number	URO180816
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that, approximately five (5) minutes after insertion, the urinary catheter balloon burst.The urinary catheter came out of the patient and a new urinary catheter was inserted without further reported incident.When the urinary catheter was reportedly inspected by the patient's nurse, the nurse noted a tear.There was no adverse impact or serious injury related to the incident.No sample was returned to the manufacturer for evaluation and a root cause was unable to be determined at this time.Due to the reported need for medical intervention to insert a new urinary catheter, 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 the urinary catheter balloon burst.
Additional Manufacturer Narrative
Sample returned for evaluation on 8/23/3021.The sample was returned for evaluation.The customer reported issue of a deflated foley catheter balloon was confirmed through visual inspection of the received sample.Based on the condition of the sample, the suspected root cause is a patient specific condition contributing towards the puncture/burst of the balloon.No additional information is available.Due to the reported incident and 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.

• Brand Name: MEDLINE
• Common Device Name: TTLVENT 16FR10ML 100%SIL UM TR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 12365158
• Report Number: 1417592-2021-00162
• Device Sequence Number: 11656784
• Product Code: OHR
• UDI-Device Identifier: 10889942687145
• UDI-Public: 10889942687145
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: URO180816
• Device Catalogue Number: URO180816
• Device Lot Number: 592191203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 12/29/2021
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown