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

Model Number 303416A

Device Problem Material Discolored (1170)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  malfunction  

Event Description

Four (4) lubri-sil ic complete care urinary catheter trays opened with each having a discolored (tan to brown color) urinary catheter; 3 kits ngex4788 exp: 2023-01-31, 1 kit ngey3206, exp: 2023-03-31.Fda safety report id # (b)(4).

• Brand Name: LUBRI-SIL I.C. COMPLETE CARE FOLEY CATHETER TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD MEDICAL / C.R. BARD, INC. ; covington GA 30014
• MDR Report Key: 12108499
• MDR Text Key: 260544827
• Report Number: MW5102273
• Device Sequence Number: 3
• 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: 06/30/2021
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Device Lot Number: NGEX4788
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2021
• 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: 49 YR