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

Catalog Number	0166V16S
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/11/2025
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 the patient diagnosis of urinary retention was clear and catheterization and indwelling catheterization were recommended to improve symptoms.A urinary foley catheter was placed from (b)(6) 2025, and was found to be dislodged during bladder irrigation, and the suprapubic balloon did not fill up after filling with water.The urinary catheter balloon flowed out on its own after filling with water.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be user related (example: contact with sharp object)/mechanical failure/operator error/thin rubberize layer).Pfmea ra87p002 rev 19 (rubberize dipping process) was reviewed for this investigation.The failure mode is addressed in step/item # 4.A potential root cause for this failure mode could be insufficient latex strength, low/non-uniform rubberize thickness, wire pressing technique, stripping technique etc.That cause the torn rubberize.Based on information in the fmea, the risk of this failure is medium.Current controls in place are adequate to mitigate this failure mode.A review of the device labelling has been conducted for investigation purposed.The ifu is attached in the investigation overview element.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Therefore, no additional action required at this time.Correction: d.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 patient diagnosis of urinary retention was clear and catheterization and indwelling catheterization were recommended to improve symptoms.A urinary foley catheter was placed from (b)(6) 2025, and was found to be dislodged during bladder irrigation, and the suprapubic balloon did not fill up after filling with water.The urinary catheter balloon flowed out on its own after filling with water.

• Brand Name: BARDEX® SILICONE COATED FOLEY CATHETER
• Common Device Name: SILICONE 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: 22383947
• Report Number: 1018233-2025-05429
• Device Sequence Number: 8663538
• Product Code: KOD
• UDI-Device Identifier: 00801741039492
• UDI-Public: (01)00801741039492(11)231212(17)280701(10)MYHW1935
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 0166V16S
• Device Lot Number: MYHW1935
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/12/2023
• 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