MAUDE Adverse Event Report: ICU MEDICAL, INC. NONVENTED SET FOR TRANSURETHRAL RESECTION PROCEDURES 96 INCH; CATHETER, IRRIGATION

Lot Number 3863919

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/27/2019

Event Type  malfunction  

Event Description

There is an approximately 4" piece of flexible silicone tubing attached to the urological adapter on the t-u-r y-set that must be removed when the set is used for continuous bladder irrigation (cbi).This piece of flexible tubing can be difficult if not impossible to pull off by hand.The company does not give a solution on how to properly remove or provide the product without the piece.Removal of the piece is not addressed in the ifu.This issue is a potential contributing factor in the development of a catheter associated urinary tract infection event(s).Fda safety report id#: (b)(4).

• Brand Name: NONVENTED SET FOR TRANSURETHRAL RESECTION PROCEDURES 96 INCH
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): ICU MEDICAL, INC.
• MDR Report Key: 8793807
• MDR Text Key: 151433939
• Report Number: MW5088153
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3863919
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 92 YR