MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. 5CC LATEX FOLEY CATHETER WITH SILVER/HYDROGEL COATING,2-WAY,; FOLEY CATHETER (LATEX)

Model Number 0165SI14

Device Problem No Flow (2991)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/15/2016

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 urine would not flow through the catheter during use.On the in house observation, there was no difficulty to inject water into the drainage lumen on the returned sample.The sample is no longer available for evaluation.

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: "indications for use: the bardex® i.C.Latex foley catheter is indicated for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as nephrostomy tract.Directions for use: visually inspect the product for any imperfections or surface deterioration prior to use.If package is opened or if any imperfection or surface deterioration is observed, do not use.Using proper aseptic methods, remove catheter from package.Prepare patient per hospital/nursing recommended procedure.Proceed with catheterization using standard techniques.Inflate the balloon with sterile water to the volume stated on the inflation lumen of the catheter by using a water-filled luer tip syringe.Connect catheter to collection container.To deflate the balloon, gently reinsert the luer tip syringe into the valve and aspirate.Caution: to deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure in the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and /or lead to injury, illness or death of the patient.Valve type: use luer slip tip syringe.Do not use needle.Do not exceed recommended capacities as stated on the inflation lumen of the catheter.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: do not aspirate urine through drainage funnel.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage latex and may cause balloon to burst.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Caution: this product contains natural rubber latex which may cause allergic reactions.Sterile unless package is opened or damaged.Do not use if package is damaged.Recommended indwelling time not to exceed 28 days." (b)(4).

Event Description

It was reported that urine would not flow through the catheter during use.On the in house observation, there was no difficulty to inject water into the drainage lumen on the returned sample.The sample is no longer available for evaluation.

• Brand Name: BARDEX I.C. 5CC LATEX FOLEY CATHETER WITH SILVER/HYDROGEL COATING,2-WAY,
• Type of Device: FOLEY CATHETER (LATEX)
• 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: 6534395
• MDR Text Key: 74261747
• Report Number: 1018233-2017-02170
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016745
• UDI-Public: (01)00801741016745
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• 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: 03/31/2019
• Device Model Number: 0165SI14
• Device Catalogue Number: 0165SI14
• Device Lot Number: 5HJ8034
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2016
• Initial Date FDA Received: 05/01/2017
• 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: 09/18/2015
• 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