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

Model Number IPN050125

Device Problems Hole In Material (1293); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2018

Event Type  malfunction  

Event 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
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): TELEFLEX MEDICAL; 2917 weck dr.; research triangle park NC 27709
• MDR Report Key: 7344628
• MDR Text Key: 102598442
• Report Number: 7344628
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 04026704307968
• UDI-Public: (01)04026704307968
• 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
• Type of Report: Initial
• Report Date: 03/13/2018,03/14/2018

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
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2018
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/16/2018
• 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