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

Device Problem Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 01/01/2020

Event Type  Injury  

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 Description

It was reported that the urinary catheter was difficult to remove.

• Type of Device: TRAY TTL VENT 100%SILI UM 18FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, il ; 9311458
• MDR Report Key: 9763424
• MDR Text Key: 186542711
• Report Number: 1417592-2020-00019
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10193489513059
• UDI-Public: 10193489513059
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other