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

Catalog Number 129414

Device Problems Device Operates Differently Than Expected (2913); No Flow (2991)

Patient Problem Urinary Retention (2119)

Event Date 03/24/2016

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 there was no urine flow observed through the catheter.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "[warnings] method for use do not inflate the balloon in the urethra.[the urethra may be injured.] do not pull the catheter hard.[the bladder/urethra may be injured.] applicable patients: patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] method for use: do not reuse.Do not resterilize.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.] 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.] applicable patients: patients who are or have been allergic to natural rubber latex.Patients with known allergy to silver coated catheter.[shape, configuration and principles].Bardex¿ i.C.Temperature-sensing foley catheter is a balloon catheter with temperature- sensing.Material: balloon catheter: natural rubber latex; silver coating.This product is made with bacti-guard¿ silver alloy coating.Sizes of catheters: available in sizes 14 to 18 every 2fr.[intended use & effect- efficacy].This device is an indwelling catheter in the bladder for urinary drainage and measurement of core body temperature.The surface of catheter is coated first with a trace amount of metallic silver, and then with polyurethane onto that, to inhibit proliferation of bacteria that may adhere to the catheter.[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 the distal end of the catheter with water-soluble lubricant.Insert catheter into the urethral meatus and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a needle-less syringe, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.Pull catheter to seat the balloon at the level of the bladder neck and secure placement.Connect lead wire to monitor through extension cable.To deflate balloon and remove catheter, insert a luer tip (needleless) syringe in the inflation valve to allow the water to drain spontaneously.After balloon deflation, withdraw the catheter while confirming that no resistance is encountered.When resistance is encountered in inserting catheter, stop the procedure and remove the catheter.When deflating balloon, do not aspirate with a syringe by hands.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.].Do not stretch catheter as damage to or dislodgement of lead wire as temperature probe may cause improper temperature measurement.When endoelectric surgery is performed, care should be taken to prevent burns in the local tissue.Do not wet the lead wire and the junction with extension cable.This device is compatible only with monitors requiring ysi 400-series type temperature probes.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.] do not wipe catheter surface with organic solvents such as alcohol.Do not aspirate urine through drainage funnel wall.Since movement of the body, etc.May twist or bend catheter to cause occlusion, care should be taken to fix the catheter securely.When urinary flow cannot be noted, confirm that the catheter is neither occluded nor broken.[precautions]: precautions for use (exercise caution when using the device in the following patients).Exercise caution when using the device in patients with high urinary calcium levels as encrustation on the balloon surface, catheter occlusion or damage may occur.Important precautions: when catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, defect, etc.Before inserting a new catheter.When any part of the balloon and/or the catheter is missing, consider removing them using a cystoscope.When it is difficult to remove catheter by deflating the balloon, take appropriate measures according to the section troubleshooting.Troubleshooting: when it is difficult to remove catheter by deflating the balloon (expressed as removal-difficult case hereinafter), take appropriate measures according to the following procedures.The following two methods are available for removal-difficult cases.A.Non-rupture method (sterile water is withdrawn without bursting the balloon.).B.Balloon-rupture method.With balloon-rupture method, fragments of the ruptured balloon may remain in the bladder.Therefore, try non-rupture method first.A.Non-rupture method: attach luer tip syringe to the inflation valve.Inject an additional amount of sterile water into the inflation lumen and pump the plunger.If situation wouldn't be improved with sever the inflation funnel of valve.If situation wouldnt be improved with sever the catheter shaft while holding it with forceps so that the distal segment may not be drawn into the urethra.If situation wouldn't be improved with insert a needle into the inflation lumen and pump the plunger.If situation wouldn't be improved with insert a fine steel wire through the inflation lumen of catheter.B.Balloon-rupture method: inject 100-200ml/cc of saline solution warmed to body temperature into the bladder through the drainage lumen, and then inject a large amount of water into the balloon through the inflation lumen with a needle to induce rupture.After rupture of the balloon, irrigate the bladder.If situation wouldn't be improved with 1), attempt following procedures.Under the radioscopic observation, infuse a contrast medium into the bladder, and burst the balloon by suprapubic puncture of the bladder.In male patients, burst the balloon by puncture with a needle from the perineal (or suprapubic) region or through the rectum under ultrasonographic guidance.In female patients, burst the balloon by insertion of a needle along the urethra.Mri safety: based on non-clinical studies, mri safety for the device is confirmed under the following conditions: static magnetic field of 3-tesla or less with regard to magnetic field interactions.Spatial gradient magnetic field of 720-gauss/cm or less with regard to magnetic field interactions.Maximum mr system reported whole-body-averaged specific absorption rate (sar) of 3.5-w/kg at 1.5- or 3-w/kg at 3-tesla for 15 minutes of scanning.The position of the wire of the foley catheter with temperature sensor has an effect on the amount of heating that may develop during an mri procedure.Accordingly, the foley catheter with temperature sensor must be positioned in a straight configuration down the center of the patient table (i.E., down the center of the mr system without any loop) to prevent possible excessive heating associated with an mri procedure.Importantly, the mri procedure should be performed using an mr system operating at a static magnetic field strength of 1.5-tesla or 3-tesla only.The safe use of an mr system operating at lower or higher field strength for a patient with a foley catheter with temperature sensor has not been determined.If the foley catheter with temperature sensor has a removable extension cable, it should be disconnected prior to the mri procedure.Remove all electrically conductive material from the bore of the mr system that is not required for the procedure (i.E., unused surface coils, cables, etc.).Keep electrically conductive material that must remain in the bore of the mr system from directly contacting the patient by placing thermal and/or electrical insulation including air between the conductive material and the patient.Malfunction and adverse events: malfunction: catheter kinking, damage, rupture, difficulty or failure to remove the device, occlusion of catheter inner lumens, encrustation, accidental removal of the device due to leakage of sterile water or balloon rupture, device damage due to inappropriate use, failure to measure temperature, improper temperature indication.Adverse events: urinary-tract infection, hemorrhage, hematuria, allergy reaction to the device, calculus formation, edema, pain, discomfort, injury of bladder or urethral, urethritis, urinary incontinence, retained balloon fragments.[storage method and expiration date]: storage: store in a dry, cool place away from heat, moisture, and direct sunlight.Expiration date: indicated on the direct package and the outer box" (b)(4).

Event Description

It was reported that there was no urine flow observed through the catheter.

• Brand Name: BARDEX® I.C. TEMPERATURE-SENSING FOLEY CATHETER
• Type of Device: TEMPERATURE SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; lot 57c; covington GA 30014
• Manufacturer Contact: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6522766
• MDR Text Key: 73837598
• Report Number: 1018233-2017-02091
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

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: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 129414
• Device Lot Number: 5HM7040
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: 08/07/2017
• Supplement Dates FDA Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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