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

Catalog Number	URO180716
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Email received from materials manager, adams memorial hospital, with additional information related to this incident.It was reported; two silicone 1- layer foley catheter with drain bag had defective bulbs.Catheters had been inserted, bulbs inflated and each time the catheters fell out and the bulbs were not inflated.Third attempt with new catheter was successful.Reporter confirms this incident occurred 12/3/2020 after a nurse had attempted to place and secure each catheter into a female patient.Reporter states, catheter ordered by patient's physician for labor epidural.Reporter states, "that later in third shift the catheter was anchored without issue." reporter states, no serious injury reported no samples available for return and evaluation.No further information at this time.Due to the reported incident, medical intervention 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.
Event or Problem Description
It was reported, two silicone 1- layer foley catheter with drain bag's had defective bulbs.Catheters had been inserted, bulbs inflated and each time the catheters fell out and the bulbs were not inflated.Third attempt with new catheter was successful.

• Common Device Name: TTLVENT 16FR10ML 100%SIL DB TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11032225
• Report Number: 1417592-2020-00152
• Device Sequence Number: 13711742
• Product Code: OHR
• UDI-Device Identifier: 10889942687084
• UDI-Public: 10889942687084
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2020

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 Catalogue Number: URO180716
• Device Lot Number: 19JBE266
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 12/17/2020
• 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