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

Catalog Number	2551H22
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2025
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.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 there was a crack in the foley catheter, and it was said that sterile water leaked during the pre-test.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received (6) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), foley catheter.Visual inspection of the sample noted using the (in-house) syringe attempted to inflate and the solution immediately leaked out of pinhole measuring less than 0.013mm.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: warnings method for use: 1.Since it may be difficult to remove catheter even after balloon deflation in some cases, the catheter should be removed under the e physician¿s instructions by reference to the section ¿troubleshooting¿.2.When deflating balloon, allow balloon to deflate on its own; do not aspirate with a syringe.The inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the balloon cannot be removed.3.When catheter is inadvertently removed, inspect the balloon and shaft of catheter for rupture, damage, etc.Before inserting a new catheter.Fragments of the balloon or segment of catheter may remain in the bladder.4.When inserting catheter with a stylet, confirm that the stylet has reached the tip of the catheter, and then insert without pulling them back.Otherwise, the stylet may exit the side hole to damage the urethral mucosa.Caution should be exercised in the following patients: use with great care for patients with disturbance of consciousness, etc.When patient removes catheter unconsciously, the mucosa of the bladder and urethra may be damaged, balloon may be ruptured, catheter may be broken, and catheter fragments may be left behind in the bladder.Contraindications & prohibitions method for use: 1.Do not reuse.2.The balloon and shaft of catheter should not be pinched with forceps, etc.And avoid contacting the catheter with a blade or sharp -edged devices.The re is a strong likelihood that breakage or inadvertent removal of catheter, or rupture of balloon will occur, and that inability of balloon to deflate may make removal of the catheter difficult.This product is contraindicated in the following patients: 1.Patients with a past history of allergic reactions to natural rubber.Prohibited concomitant use 1.Do not use ointments, contrast medium or lubricants having oily base, including the mineral oil such as white petroleum, vegetal oil such as olive oil, or animal oil and fat.They will damage catheter and may cause balloon to burst.2.Do not wipe catheter surface with organic solvents such as alcohol.3.No substance except sterile water should be used to inflate the balloon.If contrast medium is used, balloon may burst.If normal saline is used, crystallized salt may occlude the inflation lumen to prevent deflation of the balloon.If air is used, air may escape to cause inadvertent deflation of the balloon so that the catheter may come out prematurely.Indications for use this device is an indwelling catheter in the bladder for urinary drainage, bladder irrigation and hemostasis.Instructions for use 1.Cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.2.After opening the package, care should be taken to avoid contamination.Lubricate the shaft of catheter.3.Carefully insert catheter into the urethral meatus, and advance it until the balloon enters the bladder.Using a needle-less syringe, gently infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.4.Pull catheter slightly to seat the balloon at the level of the bladder neck.5.To deflate balloon and remove catheter, gently insert a luer tip (needleless) syringe in the inflation valve.Even without aspiration, sterile water in the balloon will come out spontaneously through balloon deflation.After balloon deflation, withdraw the catheter slowly while confirming that no abnormal resistance is encountered.Malfunction and adverse events difficulty during catheter removal due to non-deflator balloon inadvertent catheter dislodgement due to damaged catheter and/or balloon burst storage method and expiration date 1.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.2.Expiration date: indicated on the direct package and the outer box.Correction: d, h 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 there was a crack in the foley catheter, and it was said that sterile water leaked during the pre-test.

• Brand Name: BARDEX® LUBRICATH® HEMATURIA 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21805911
• Report Number: 1018233-2025-02478
• Device Sequence Number: 18351438
• Product Code: KOD
• UDI-Device Identifier: 00801741025150
• UDI-Public: (01)00801741025150(11)240222(17)290128(10)MYJN5736
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K922431
• 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): 07/28/2025

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: 2551H22
• Device Lot Number: MYJN5736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2024
• 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