MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX)

Model Number 0165SI14

Device Problems Inaccurate Flow Rate (1249); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/07/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that no urine flowed from the catheter after the placement.The catheter was replaced with another one.

Event Description

It was reported that no urine flowed from the catheter after the placement.The catheter was replaced with another one.

Manufacturer Narrative

The reported event was unconfirmed since the problem could not be reproduced.Evaluation found no blockage observed in drainage lumen.Water was introduced through the drainage funnel and came out from drainage eye without difficulty.Sample was sent for flow rate test and passed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[warnings] 1.Method for use (1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) patients who are or have been allergic to natural rubber latex (2) patients with known allergy to silver coated catheter [directions for use] 1.Method of use the device is intended for single use only and is not reusable.(6) insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.2.Precautions for use (1) when resistance is encountered in inserting catheter, stop the procedure and remove the catheter.(2) when deflating balloon, do not aspirate with a syringe.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.] (3) no substance except sterile water should be used to inflate the balloon.[if contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the balloon so that the catheter may come out prematurely.] (4) do not wipe catheter surface with organic solvents such as alcohol.(5) do not aspirate urine through drainage funnel wall.(6) since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.(7) when urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.".

• Brand Name: BARDEX I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10111611
• MDR Text Key: 193945761
• Report Number: 1018233-2020-03517
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 08/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: 9NB049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Date Manufacturer Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1