MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY TTL VENT 100%SILI UM 18FR

Health Effect - Clinical Code	No Code Available (3191)
Date of Event	01/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported that the urinary catheter was difficult to remove and that when it was removed, the device was noted to have a "ring" in the area of the retention balloon.According to the reporting facility, the patient experienced "urethral trauma and bleeding." despite multiple good faith attempts the reporting facility was unable or unwilling to provide additional information to the manufacturer.A sample of only the tip of the urinary catheter was returned to the manufacturer for evaluation.Inspection of the urinary catheter tip identified that it was cut just below the length of the retention balloon.The retention balloon was noted to have not returned to its original shape and the lumen of the retention balloon was found to be cuffed.If the retention balloon is not passively deflated, the introduction of negative pressure may lead to lumen cuffing and difficult removal of the urinary catheter.Based on the condition of the returned sample, the suspected root cause is improper deflation of the retention balloon.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the urinary catheter was difficult to remove.

• Common Device Name: TRAY TTL VENT 100%SILI UM 18FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9763424
• Report Number: 1417592-2020-00019
• Device Sequence Number: 19004918
• Product Code: EZL
• UDI-Device Identifier: 10193489513059
• UDI-Public: 10193489513059
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/27/2020

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?: No
• Operator of Device: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/28/2020
• Initial Report FDA Received Date: 02/27/2020
• 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: Other