MAUDE Adverse Event Report: TELEFLEX MEDICAL IDA BUSINESS & TECHNOLOGY 24FR TELEFLEX RUSCH SILICONE FOLEY 30MLBALLOON CATHETER 3WAY; FOLEY CATHETER

Catalog Number	173830240
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Two(2) 3way catheters from same lot had balloon rupture.Two separate locations.Using a 60 ml syringe to inflate 30ml of saline balloon.

• Brand Name: 24FR TELEFLEX RUSCH SILICONE FOLEY 30MLBALLOON CATHETER 3WAY
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL IDA BUSINESS & TECHNOLOGY ; kamunting, perak ; MY
• MDR Report Key: 7596081
• Report Number: MW5077801
• Device Sequence Number: 16492860
• Product Code: KOD
• UDI-Device Identifier: 04026704334889
• UDI-Public: 04026704334889
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/11/2018
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/28/2022
• Device Catalogue Number: 173830240
• Device Lot Number: 17KE44
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Weight: 84