MAUDE Adverse Event Report: CR BARD INC SURESTEP FOLEY TRAY SYSTEM WITH LUBRICATH TEMPERATURE SENSING FOLEY CATHETER; CATHETER, URINARY

Catalog Number 119216M

Device Problems Material Protrusion/Extrusion (2979); Scratched Material (3020)

Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Swelling (2091); Hematuria (2558)

Event Date 09/07/2015

Event Type  malfunction  

Event Description

A temperature sensing foley catheter was placed in an adult male on admission - 7 days later nurse noted that the foley's sensing probe wire was protruding out of 50% of the catheter causing what looked and felt like a serrated edge.This rough spot of the catheter was rubbing against the meatus of the penis, resulting in hematuria with large clots in the urine.There was also bleeding and inflammation with swelling around the catheter entry point.The foley was immediately removed.

• Brand Name: SURESTEP FOLEY TRAY SYSTEM WITH LUBRICATH TEMPERATURE SENSING FOLEY CATHETER
• Type of Device: CATHETER, URINARY
• Manufacturer (Section D): CR BARD INC; 730 central ave.; murray hill NJ 07974
• MDR Report Key: 5131051
• MDR Text Key: 27629535
• Report Number: 5131051
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Report Date: 10/01/2015

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
• Device Operator: No Information
• Device Catalogue Number: 119216M
• Other Device ID Number: NGZC3580
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/01/2015
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO
• Patient Outcome(s): Other
• Patient Age: 70 YR