MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI C UM TRAY

Catalog Number URO170816CN

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that the urinary catheter came out of the patient after an unknown period of time post-insertion.The urinary catheter balloon was still inflated at the time of the incident.Reportedly, a new urinary catheter was inserted without further reported incident.No impact to the patient or the patient's stability was reported to the manufacturer.The urinary catheter involved in this incident was discarded.No sample was returned to the manufacturer for evaluation.A root cause for the reported product issue could not be determined.Due to the 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 Description

It was reported that the urinary catheter came out of the patient and a new urinary catheter was required to be inserted.

• Type of Device: TTL1LYR 16FR10ML 100%SILI C UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8565076
• MDR Text Key: 143712523
• Report Number: 1417592-2019-00058
• Device Sequence Number: 1
• Product Code: OHR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/30/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: URO170816CN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 04/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention