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

Catalog Number URO180716

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/03/2020

Event Type  malfunction  

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 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.

• Type of Device: TTLVENT 16FR10ML 100%SIL DB TR
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093 ; 2249311514
• MDR Report Key: 11032225
• MDR Text Key: 223618772
• Report Number: 1417592-2020-00152
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10889942687084
• UDI-Public: 10889942687084
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO180716
• Device Lot Number: 19JBE266
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention