MAUDE Adverse Event Report: C. R. BARD, INC. SURESTEP FOLEY TRAY SYSTEM 16 FRENCH COUDE; CATHETER COUDE

Lot Number NGDX4745

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 01/02/2020

Event Type  malfunction  

Event Description

This product did not reach a pt.When staff opened up the 16 french coude catheter kit, they noted the catheter to be misplaced within the kit and there was paper residue on the catheter itself.Staff opened up three more kits with the same lot numbers and noted the same concerns.Fda safety report id# (b)(4).

• Brand Name: SURESTEP FOLEY TRAY SYSTEM 16 FRENCH COUDE
• Type of Device: CATHETER COUDE
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 9569236
• MDR Text Key: 174668684
• Report Number: MW5092107
• Device Sequence Number: 2
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/06/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: NGDX4745
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1