MAUDE Adverse Event Report: C.R. BARD, INC. FOLEY CATHETER TRAYS; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number [A]319516AM

Device Problems Material Discolored (1170); Device Sensing Problem (2917); Temperature Problem (3022)

Patient Problem Insufficient Information (4580)

Event Date 06/11/2021

Event Type  malfunction  

Event Description

Ten (10) various bard lubri-sil i.C.Complete care with and without temperature sensing and sure step urinary catheter trays with discolored (clear transitioning to tan/brown) urinary catheters.Fda safety report id# (b)(4).

• Brand Name: FOLEY CATHETER TRAYS
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C.R. BARD, INC.
• MDR Report Key: 12008111
• MDR Text Key: 256708683
• Report Number: MW5101901
• Device Sequence Number: 2
• Product Code: MJC
• 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: 06/11/2021
• 10 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: [A]319516AM
• Device Catalogue Number: [A]319516AM
• Device Lot Number: NGE20708
• 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
• Patient Age: 43 YR