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

Catalog Number	0165SI18
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2025
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.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 the patient stated that this morning when she woke up the foley fell out and she had to replace.Patient stated that the balloon did not inflate properly when inserted.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.
Event or Problem Description
It was reported the patient stated that this morning when she woke up the foley fell out and she had to replace.Patient stated that the balloon did not inflate properly when inserted.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.It was unknown whether the product had caused the reported failure.The potential root cause for this failure could be pinch lumen/collapse lumen/thick sac thickness/valve damage/short inflation lumen.Pfmea ra87p002 rev 19 (rubberized 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 due to collapsed/pinched inflation lumen under the balloon or along the shaft.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 labeling have been conducted for investigation purpose.The ifu is attached on 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 is required at this time.Correction: a.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.

• Brand Name: BARDEX® I.C. 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: 22494716
• Report Number: 1018233-2025-05812
• Device Sequence Number: 4106907
• Product Code: MJC
• UDI-Device Identifier: 00801741016769
• UDI-Public: (01)00801741016769
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• 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: 0165SI18
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 07/14/2025
• 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