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

Model Number	0168SI16
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Codes	Rash (2033); Patient Problem/Medical Problem (2688)
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 patient experienced a rash in the groin and axilla after the urinary catheter was placed.The catheter could not be removed manually by the nurse, so urology had to be called in for assistance.
Event or Problem Description
It was reported that the patient experienced a rash in the groin and axilla after the urinary catheter was placed.The catheter could not be removed manually by the nurse, so urology had to be called in for assistance.It was later reported that the urologist made multiple attempts to remove the balloon, which included an attempt to removal fluid, with no return, cut the catheter proximal to the y, with no release.A guide wire was then inserted through the inflation channel, with no success.Subsequently, the guide wire was used to place a small hole in the balloon.The urologist was then able to deflate the balloon with gentle traction on the bladder neck.
Additional Manufacturer Narrative
The reported event was confirmed, however, the cause is unknown.An amber bardex catheter was returned cut into three pieces without its original packaging.The portion containing the inflation funnel was infused with water using a leur lock syringe.No occlusions were found.The other pieces were checked and the middle of the shaft revealed a blocked inflation lumen.The blockage material appeared to be grey in color, but the cause of the blockage is unknown.The device failed to meet specifications.The device was being used for treatment.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: ¿c.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 bard limited forest house brighton road crawley, west sussex rh11 9bp u.K.0044 1293 527 888 ® bard infection control system bardex® i.C.Anti-infective foley catheter caution: this product contains natural rubber latex which may cause allergic reactions.Pk7631273 08/2009 to deflate catheter balloon: gently insert a luer slip 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 copyright ©2009 c.R.Bard, inc.All rights reserved.Balloon fragments have been removed from the patient.U.S.Patent nos.5,320,908; 5,395,651; 5,747,178; 5,965,204; 6,224,983; and patents pending canadian patent no.2,016,081; australian patent no.642,872 peel to open with bard® hydrogel and bacti-guard®* silver alloy coating the occurrence of uti is 3.7 times greater in patients catheterized with a standard catheter than in patients catheterized with the bardex® i.C.Foley catheter with bard® hydrogel and bacti-guard®* silver alloy coating (95 c.I.2.0-6.8).Bard, bardex, and the i.C.Logo are trademarks and/or registered trademarks of c.R.Bard, inc.Or an affiliate.Bacti-guard is a registered trademark of bactiguard ab.*bacti-guard® silver alloy coating is licensed from bactiguard ab.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheterrelated adverse effect, the catheter should be replaced.Do not exceed recommended capacities.Sterile: unless package is opened or damaged.Do not use if package is opened or damaged.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Visually inspect the product for any imperfections or surface deterioration prior to use.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst." 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.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.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 patient experienced a rash in the groin and axilla after the urinary catheter was placed.The catheter could not be removed manually by the nurse, so urology had to be called in for assistance.It was later reported that the urologist made multiple attempts to remove the balloon, which included an attempt to removal fluid, with no return, cut the catheter proximal to the y, with no release.A guide wire was then inserted through the inflation channel, with no success.Subsequently, the guide wire was used to place a small hole in the balloon.The urologist was then able to deflate the balloon with gentle traction on the bladder neck.

• Brand Name: BARDEX® I.C. CARSON MODEL COUDE TIP FOLEY CATHETER
• Common Device Name: LATEX FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9654837
• Report Number: 1018233-2020-00704
• Device Sequence Number: 19460762
• Product Code: MJC
• UDI-Device Identifier: 00801741016967
• UDI-Public: (01)00801741016967
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K040658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/27/2024
• Device Model Number: 0168SI16
• Device Catalogue Number: 0168SI16
• Device Lot Number: MCDS4958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2020
• Initial Date Received by Manufacturer: 01/08/2020
• Supplement Date Received by Manufacturer: 02/10/2020; 03/19/2020
• Initial Report FDA Received Date: 01/31/2020
• Supplement Report FDA Received Date: 03/06/2020; 04/01/2020
• 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