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

Catalog Number	165818
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2025
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.Udi format updated with available product information per gudid.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 material was different (softer) which increased false paths, was more difficult to insert, which hurt the patient.Customer had a situation where the catheter had made a knot in the bladder, and they had to do a cystoscopy to cut the catheter with a laser to remove it (pcn#175812, pcn#175814, pcn#175816, pcn#175818, pcn#175820, pcn#165822 and pcn#175824).Per additional information received via mail on 06may2025, the tip of the catheter that contains the balloon is prominent and forms a ring when the balloon is deflated.It was another issue with the deflation of the balloon.The balloon remains deformed when deflated, causing injury to the patient when removing the indwelling catheter.This was apparently true for all our 100% foley (1658xx) and lubri-sil (1758xx) models.(pcn# 165820, pcn# 165818 and pcn# 165816).No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), used silicone foley.Visual inspection of the one-photo sample noted that the balloon mushroomed.This does not meet specification which states "balloon must not cuff after deflation." no actions can be taken at this time since a root cause was not identified.A dhr review is not required as the lot number is unknown.The instructions for use were found adequate and states the following: indications for use: all-silicone foley catheters are indicated for use in the drainage and/or collection and or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.Intended user: this product is intended to be used by qualified healthcare professionals.Intended use: for urological use only.Contraindication: no known contraindications.Warnings: on catheter, do not use ointments or lubricants having a petroleum base.They will damage catheter and may cause balloon to burst.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.This is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness, or death of the patient.Users and/or patients within the european union, should report any serious incident that has occurred in relation to the device to the manufacturer and the competent authority of the member state in which the user and/or patient is established.Users outside of the european union should report any serious incident that has occurred in relation to the device to the manufacturer and the regulatory authority of the country in which the user and/or patient is established.Precautions: do not use device if package is opened or damaged.Do not aspirate urine through drainage funnel wall.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Correction- d, h.Udi format updated with available product information per gudid.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 material was different (softer) which increased false paths, was more difficult to insert, which hurt the patient.Customer had a situation where the catheter had made a knot in the bladder, and they had to do a cystoscopy to cut the catheter with a laser to remove it (pcn#175812, pcn#175814, pcn#175816, pcn#175818, pcn#175820, pcn#165822 and pcn#175824).Per additional information received via mail on 06may2025, the tip of the catheter that contains the balloon is prominent and forms a ring when the balloon is deflated.It was another issue with the deflation of the balloon.The balloon remains deformed when deflated, causing injury to the patient when removing the indwelling catheter.This was apparently true for all our 100 percentage foley (1658xx) and lubri-sil (1758xx) models.(pcn# 165820, pcn# 165818 and pcn# 165816).No medical intervention was reported.

• Brand Name: BARDEX® ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 22077925
• Report Number: 1018233-2025-03817
• Device Sequence Number: 21172925
• Product Code: EZL
• UDI-Device Identifier: 00801741029769
• UDI-Public: (01)00801741029769
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

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: 165818
• 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: 05/06/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 05/23/2025
• Supplement Report FDA Received Date: 08/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Female