MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. RUSCH BRILLIANT SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number 170003060

Device Problems Detachment Of Device Component (1104); Mechanical Problem (1384); Material Protrusion/Extrusion (2979)

Patient Problems Hemorrhage/Bleeding (1888); Discharge (2225)

Event Date 03/01/2015

Event Type  malfunction  

Event Description

Attemped to place foley catheter in patient.Went to inflate balloon and syringe came off with force from catheter.When obtaining new syringe, catheter was removed slightly and blood was noted to be oozing from the tip of penis.Removed catheter completely where upon bloody discharge increased.Applied pressure and notified neonatal nurse practitioner.Stylet was noted to be protruding from the side of the catheter through a drainage hole.

• Brand Name: RUSCH BRILLIANT SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; 2400 bernville road; reading PA 19605
• MDR Report Key: 4622686
• MDR Text Key: 5591460
• Report Number: 4622686
• Device Sequence Number: 1
• Product Code: EZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/06/2015

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: Nurse
• Device Model Number: 170003060
• Device Catalogue Number: 170003060
• Device Lot Number: 14FE26
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/06/2015
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/23/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2015
• Patient Sequence Number: 1
• Patient Age: 20 DAY