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

Model Number 791600

Device Problem Insufficient Information (3190)

Patient Problems Patient Problem/Medical Problem (2688); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

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 retruded.

Event Description

It was reported that the patient had to remove the last foley surgically and there were no specifics provided.

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.Based on the event description, there is insufficient product defects information to select the applicable failure mode.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: contents of inner wrap are sterile unless package has been opened or damaged.Directions for use on reverse side.Single use only.Do not resterilize.For urological use only.Directions for use: 1.Open csr wrap to form sterile field.2.Place underpad beneath patient, plastic side down.3.Put on cuffed gloves.4.Position drape on patient.5.Remove top tray.6.Open lubricant packet.Lubricate catheter.7.Pour cleansing solution onto prep balls.8.Prep patient with saturated prep balls.9.Proceed with catheterization in usual manner.10.If specimen is required, fill sterile container from catheter.11.Top tray may be placed on basin to help prevent spillage.12.If urine is placed in specimen jar: a.Secure cap.B.Label specimen jar.C.Send specimen to laboratory.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 within 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.Allow the balloon to deflate slowly on its own.Do not aspriate or manually accelerate the deflation of the ballloon.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.Volume on collection container has been calibrated without uro-prep tray in place.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheter.Warning: 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.Warning: on catheter, do not use ointments or lubricants having a petrolatum base.They will damage the silicone and may cause the balloon to burst.Wait at least 30 seconds for balloon deflation inflate with 10ml sterile water.Bard, bardex and uro-prep are trademarks and/or registered trademarks of c.R.Bard, inc.©2010 c.R.Bard, inc.All rights reserved." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the patient had to remove the last foley surgically and there were no specifics provided.

• Brand Name: CATHETERIZATION TRAY WITH 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
• MDR Report Key: 10526245
• MDR Text Key: 206714226
• Report Number: 1018233-2020-05865
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741029653
• UDI-Public: (01)00801741029653
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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?: No
• Device Operator: Lay User/Patient
• Device Model Number: 791600
• Device Catalogue Number: 791600
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/13/2020
• Supplement Dates Manufacturer Received: 12/02/2020
• Supplement Dates FDA Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention