MAUDE Adverse Event Report: C. R. BARD, INC. FOLEY SIL 2-WAY 16 FR 5CC; CATHETER, RETENTION TYPE, BALLOON

Device Problems Use of Device Problem (1670); Improper Flow or Infusion (2954)

Patient Problems Urinary Retention (2119); Chemical Exposure (2570)

Event Date 12/22/2022

Event Type  malfunction  

Event Description

Rn (registered nurse) placed the foley and then the chemo drug, gemzar, was instilled in the bladder at 1132.There was a clamp placed on the foley tubing.Rn returned from lunch at 1230, another rn reported that the clamp needed to be removed from the foley tubing at 1232.Rn removed the clamp from the foley and saw urine passing through the foley tubing.Later, the resident asked the rn where was the foley.Rn found the foley by the head of the bed and showed resident.He noted that there was about 175 in the foley bag.Rn reminded him that 50cc of gemzar had been instilled in the bladder, so he documented 125 of urine output.Around 1500 the robot was undocked, and the patient was repositioned, and at that time it was noted that the foley was on the ground.At 1505, resident replaced the foley and immediately 500cc of urine came out of the bladder into the newly placed bag.Surgeon was present and did not state that anything else needed to be done.Rn asked resident how much urine output he had documented in total.He had charted the previous 125 for the 1130 output.Because of the chance that gemzar might have been in the bladder longer than the recommended one-hour instillation.

• Brand Name: FOLEY SIL 2-WAY 16 FR 5CC
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd.; covington GA 30014
• MDR Report Key: 16852611
• MDR Text Key: 314391634
• Report Number: 16852611
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/02/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 24820 DA
• Patient Sex: Female
• Patient Weight: 64 KG