MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH HYDROPHILIC-COATED FOLEY CATHETER; 16 FR SILICONE CATHETER

Model Number	861016
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the silicone foley balloon would not deflate after being placed for approximately two hours.The nurse was initially able to remove approximately 7ml from the balloon injection port but resistance remained at that time.The urologist was called in and attempted to deflate the balloon further with probes through the injection channels and was unsuccessful.The catheter was cut in addition to a stylet being used to puncture the balloon.
Additional Manufacturer Narrative
The reported event was inconclusive due to the poor sample condition.Based on the photo attached, a complete evaluation could not be performed.How and when problem occurred could not be determined.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: "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 latex and may cause balloon to burst.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.1.Open csr wrap to form sterile field and place underpad beneath patient, plastic side down.2.Put on cuffed gloves and position drape on patient.3.Pour cleansing solution onto three prep balls.4.Open catheter lubricating jelly.5.Remove top tray and open plastic pouch surrounding catheter.6.Lubricate catheter.7.Prepare patient with saturated prep balls.Dry patient with remaining 2 prep balls.8.Proceed with catheterization in usual manner.To inflate catheter, simply insert tip of water-filled syringe gently into valve (do not overpenetrate) and depress plunger.Instill entire amount of sterile water (10cc).9.Position hanger on bed frame near foot of bed and use sheeting clip to secure drainage tube to draw sheet.10.To empty bag: a.Remove outlet tube from housing; gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying, reclamp outlet tube and slide connector into housing until connector arms engage.11.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.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.12.Periodic observations of this system should be made to ensure that urine is flowing freely.If a standing column of urine is observed, check for correct positioning of bag and then for a physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Tamper-evident seal disconnect instructions: if necessary to disconnect catheter and drainage tube connector, flex catheter as illustrated, grasp tab and slowly pull along perforations until section is removed.Directions for using bard ez-lok® sampling port: bard ez-lok® sampling port accepts a luer-lock or slip tip syringe.1.Kink drainage tubing a minimum of 3 inches below the sampling port until urine is visible under the access site.2.Swab surface of site with antiseptic wipe.3.Using aseptic technique, position the syringe in the center of the sampling port.The syringe should be held perpendicular to the surface of the sampling port (at approximately 80-100 degree angle).Press the syringe firmly and twist gently to lock the syringe onto the sampling port.Note: improper penetration technique could cause formation of a drop of urine on the surface of the sampling port.Periodic observation of the sampling port is recommended.4.Aspirate desired volume of urine.5.Unkink tubing and send specimen to laboratory".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.
Event or Problem Description
It was reported that the silicone foley balloon would not deflate after being placed for approximately two hours.The nurse was initially able to remove approximately 7ml from the balloon injection port but resistance remained at that time.The urologist was called in and attempted to deflate the balloon further with probes through the injection channels and was unsuccessful.The catheter was cut in addition to a stylet being used to puncture the balloon.

• Brand Name: BARD® FOLEY TRAY WITH HYDROPHILIC-COATED FOLEY CATHETER
• Common Device Name: 16 FR SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8888203
• Report Number: 1018233-2019-04688
• Device Sequence Number: 13537067
• Product Code: EZC
• UDI-Device Identifier: 00801741040399
• UDI-Public: (01)00801741040399
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2021
• Device Model Number: 861016
• Device Catalogue Number: 861016
• Device Lot Number: NGBY1706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Initial Date Received by Manufacturer: 07/22/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention