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

Catalog Number	0119L20
Medical Device Problem Codes	Material Puncture/Hole (1504); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2024
Type of Reportable Event	Malfunction
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 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 foley catheter came out soon after insertion (the exact placement time was still being confirmed), and in the director's case, three consecutive cases in the same patient (20fr, 18fr) a stone has come out and said that the cuff should not be damaged because of that, and have had major trouble with this director in the past due to a balloon malfunction, need to be careful.Per additional information received via email on 16jul2024, it was reported that the damage to the cuff which was visible to the naked eye.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Evaluation confirmed the balloon was burst.Introduced water into the inflation lumen and did not experience any obstructions to impede flow.Microscopic examination found there was present salt on the balloon area.However, the exact cause of how and when the problem occurred could not be determined.The potential root cause for this failure could be user related (example: contact with sharp object)/ exposure to petrolatum based products/ mechanical failure/operator error).A potential root cause for this failure mode could be low latex viscosity, short latex dwell time, latex dip speed out too slow causing thin sac.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.The instructions for use were found adequate and state the following: indication for use: this device is an indwelling catheter in the bladder for urinary drainage.Precautions: 1.Precaution for use natural rubber may cause allergic symptoms including itching, redness, urticaria, swelling, fever, dyspnea, asthma-like symptoms, decrease blood pressure, shock, etc.When such symptoms appear use of the devise should be stopped immediately and consult the attending physician so that appropriate measures should be taken.2.Important precaution product is sterile unless package is opened or damaged.This device is for urological use only.Do not use for other purposes, the law restricts this device to sale by or on the order of a physician.When abnormal resistance is encountered in inserting catheter, do not use excessive force and remove the catheter to find out the cause of difficulties in insertion.When inflating or deflating balloon with sterile water, use a luer tip (needleless) syringe.Don does not use a needle.Visually inspect the product for any imperfection or surface deterioration prior to use.Do not sterilize.Use this device immediately after opening the package.After use, handle and dispose of in accordance with acceptance medical practice.Do not aspirate urine through drainage funnel wall.This may cause malfunction of catheter, or urinary tract infection.Since movement of the body 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 nether occluded nor broken.To deflate the balloon and remove catheter, gently aspiration to encourage deflation if needed.After balloon deflation withdraw the catheter at room temperature away from direct exposure to light.Inspect packaging prior to use.If packaging is opened or damage do not used.Capped adapter attached to irrigation lumen is designed to connect catheter with bladder irrigation line or tube.While in use, open the cap and attached irrigation lumen tube to it.After use cleanse the opening of lumen and close the cap.Always use aseptic technique following physician direction while using irrigation lumen.This report references a us equivalent device.The us udi equivalent for this product number is used h11: section a through f - the information provided by bd represents all 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 foley catheter came out soon after insertion (the exact placement time was still being confirmed), and in the directors case, three consecutive cases in the same patient (20fr , 18fr ) a stone has come out and said that the cuff should not be damaged because of that, and have had major trouble with this director in the past due to a balloon malfunction need to be careful.Per additional information received via email on 16jul2024, it was reported that the damage to the cuff which was visible to the naked eye.

• Brand Name: BARDEX® LUBRICATH® FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19781810
• Report Number: 1018233-2024-04376
• Device Sequence Number: 15492330
• Product Code: EZC
• UDI-Device Identifier: 00801741019074
• UDI-Public: (01)00801741019074(11)231128(17)280728(10)MYHW1975
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K910846
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 0119L20
• Device Lot Number: MYHW1975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2024
• Supplement Date Received by Manufacturer: 07/25/2024
• Initial Report FDA Received Date: 07/19/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown