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

Catalog Number	0167V16S
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, at 11:30 a.M, a patient with urinary retention was admitted to the department for treatment.Following medical instructions, a disposable sterile urinary foley catheter was inserted into the patient.After insertion, urine flowed smoothly, and the patient reported no particular discomfort.The patient was given instructions on precautions to take.At 6:00 p.M., after the patient returned home, the urinary catheter was fell out.Upon inspection, the disposable sterile urinary catheter's water bag was found to be ruptured.It was immediately replaced.
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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It is unknown whether the device had met relevant specifications.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)/ exposure to petrolatum based products/ mechanical failure/operator error).Pfmea ra87p003, rev 23 (sac manufacturing process) was reviewed for this investigation.The reported event is addressed in step/item#3.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.Based on information in the pfmea, 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.The dhr review could not be performed without a lot number.Therefore, no additional action required at this time.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 on (b)(6) 2025, at 11:30 a.M, a patient with urinary retention was admitted to the department for treatment.Following medical instructions, a disposable sterile urinary foley catheter was inserted into the patient.After insertion, urine flowed smoothly, and the patient reported no particular discomfort.The patient was given instructions on precautions to take.At 6:00 p.M., after the patient returned home, the urinary catheter was fell out.Upon inspection, the disposable sterile urinary catheter's water bag was found to be ruptured.It was immediately replaced.

• Brand Name: BARDEX® FOLEY CATHETER SILICONE COATED
• 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: 22437053
• Report Number: 1018233-2025-05617
• Device Sequence Number: 3127289
• Product Code: KOD
• UDI-Device Identifier: 00801741019203
• UDI-Public: (01)00801741019203
• 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: 0167V16S
• 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: 07/04/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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