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

Model Number 165816

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.The device was not returned.

Event Description

It was reported that the catheter was leaking water from a hole between the lumens, therefore the catheter balloon prematurely deflated.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "[directions for use].Method of use the device is intended for single use only and is not reusable.Precautions for use cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.Lubricate catheter shaft with water-soluble lubricant.Carefully insert catheter into the urethral meatus, and advance it until the balloon enters the bladder.Using a needleless syringe, and gently infuse the specified volume of sterile water into the valve to inflate the balloon.Never inflate the balloon without first establishing urine flow which assures that the catheter is in the bladder and there are no obstructions to urine flow.Pull catheter slightly to seat the balloon at the level of the bladder neck and secure placement.To deflate balloon and remove catheter, gently insert a luer tip (needleless) syringe in the inflation valve.Even without aspiration, sterile water in the balloon will come out spontaneously through balloon deflation.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered." (b)(4).

Event Description

It was reported that the catheter was leaking water from a hole between the lumens, therefore the catheter balloon prematurely deflated.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6844454
• MDR Text Key: 85608212
• Report Number: 1018233-2017-04617
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029752
• UDI-Public: (01)00801741029752
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/01/2017

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: Lay User/Patient
• Device Model Number: 165816
• Device Catalogue Number: 165816
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/15/2017
• Initial Date FDA Received: 09/06/2017
• Supplement Dates Manufacturer Received: 10/24/2017
• Supplement Dates FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1