MAUDE Adverse Event Report: BARD / C. R. BARD, INC. TRAY CATHETERIZATION LUBRI-SIL C; CATHETER, RETENTION TYPE, BALLOON

Model Number 303416A

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Dysuria (2684); Foreign Body In Patient (2687)

Event Date 10/18/2018

Event Type  Injury  

Event Description

Pt had a vaginal delivery on (b)(6) 2018 with a foley placed while the epidural was in place.Pt had urination discomfort, a small object 6x12 cm plastic was expelled during urination.This was the lubricant tip of the syringe in the foley kit.It would be helpful if the cap of the lubricant was not clear but instead a color.

• Brand Name: TRAY CATHETERIZATION LUBRI-SIL C
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): BARD / C. R. BARD, INC. ; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7999828
• MDR Text Key: 125033931
• Report Number: MW5080784
• Device Sequence Number: 1
• Product Code: EZL
• 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: 10/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 303416A
• Device Catalogue Number: 303416A
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 20 YR