MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALL SILICONE CATHETER; SILICONE FOLEY CATHETER

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problems Tissue Damage (2104); Urinary Retention (2119)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the silicone coude foley catheter that was inserted pre-op initially drained some urine; however there was no urine output after a significant amount of iv fluids were given to the patient.After surgery, the nurse and physician were unable to deflate the balloon to get the catheter out of the patient.The catheter was then surgically removed from the patient and the patient allegedly experienced bulbar urethral trauma related to the coude tip of the foley catheter.

Event Description

It was reported that the silicone coude foley catheter that was inserted pre-op initially drained some urine, however there was no urine output after a significant amount of iv fluids were given to the patient.After surgery, the nurse and physician were unable to deflate the balloon to get the catheter out of the patient.The catheter was then surgically removed from the patient and the patient allegedly experienced bulbar urethral trauma related to the coude tip of the foley catheter.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, a device history record could not be reviewed.Although the product family is unknown, the silicone catheter product ifus are found to be adequate based on past reviews.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8024573
• MDR Text Key: 125689197
• Report Number: 1018233-2018-05068
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/09/2019

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?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 10/31/2018
• Supplement Dates Manufacturer Received: 12/23/2018
• Supplement Dates FDA Received: 01/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention