MAUDE Adverse Event Report: C.R. BARD, INC. FOLEY CATHETER TRAY LUBRI-SIL I.C. COMPLETE CARE; CATHETER, RETENTION TYPE, BALLOON

Model Number 303416A

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/21/2021

Event Type  malfunction  

Event Description

Upon opening, the urinary catheter in the lubri-sil i.C.Complete care foley catheter tray was a tan/brown color.Fda safety report id # (b)(4).

• Brand Name: FOLEY CATHETER TRAY LUBRI-SIL I.C. COMPLETE CARE
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C.R. BARD, INC.; covington GA 60014
• MDR Report Key: 12057787
• MDR Text Key: 258618919
• Report Number: MW5102086
• Device Sequence Number: 1
• Product Code: EZL
• 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: 06/21/2021

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: NGEX4788
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/23/2021
• 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: 58 YR