MAUDE Adverse Event Report: URESIL, LLC NEPHROSTOMY TUBE NEPHRO-CATH; CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 02/19/2019

Event Type  Injury  

Event Description

The drainage tube catheter had become detached from the plastic lure lock hub.Fda safety report id# (b)(4).

• Brand Name: NEPHROSTOMY TUBE NEPHRO-CATH
• Type of Device: CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): URESIL, LLC; skokie IL 60077
• MDR Report Key: 8514542
• MDR Text Key: 142051107
• Report Number: MW5085838
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2019

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/12/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 137