MAUDE Adverse Event Report: TELEFLEX MEDICAL RUSCH; CATHETER, RETENTION TYPE, BALLOON

Model Number	IPN050125
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Foley noted to be defective.Hole in tubing (indicated between red marks on catheter).Did not negatively impact the patient.A new foley was used without incident.

• Brand Name: RUSCH
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• MDR Report Key: 7344628
• Report Number: 7344628
• Device Sequence Number: 1470491
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: (01)04026704307968
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/14/2018
• Report Date (Section F): 03/13/2018

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
• Operator of Device: Nurse
• Device Expiration Date: 04/28/2022
• Device Model Number: IPN050125
• Device Catalogue Number: 170003060
• Device Lot Number: 17EE20
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 03/13/2018