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

Catalog Number	123614A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The initial reporter's phone number:(b)(6).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: sections 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 doctor used the foley catheter on patient during surgery, after surgery they want to remove it, but they could not.User commented that balloon can be inflated but not deflated at that point of time.They decided to remove patient to ward.In ward, nurses tried to remove it but still could not deflate it.Have to send patient back to ot to remove it via laser.Surgical intervention was provided to patient.Another laser surgery was performed to remove the catheter.
Event or Problem Description
It was reported that doctor used the foley catheter on patient during surgery, after surgery they want to remove it, but they could not.User commented that balloon can be inflated but not deflated at that point of time.They decided to remove patient to ward.In ward, nurses tried to remove it but still could not deflate it.Have to send patient back to ot to remove it via laser.Surgical intervention was provided to patient.Another laser surgery was performed to remove the catheter.Per follow up information received on 17dec2025, stated that doctor used on patient during surgery, after surgery they want to remove it but couldn't.User commented that balloon can be inflated but not deflated at that point of time.They decided to remove patient to ward.In ward, nurses tried to remove it but still can't deflate it.Have to send patient back to ot to remove it via laser.
Additional Manufacturer Narrative
The reported event was inconclusive because of poor sample condition.Sample was evaluated and that the catheter was unable to be inflate.Observed water leakage from the balloon area.Microscopic examination found tear on sac body.However, the event description stated that the catheter was removed via laser after unsuccessful attempts to deflate the balloon and removed the catheter using standard practice.Thus, the reported event could not be confirmed due to the poor sample condition.The potential root cause for this failure could be user related (example: over aspirated, incorrect syringe/collapse lumen/sac close eye/valve damage).A review of the device labeling has been conducted for investigation purposed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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: BARDIA® 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: 23769538
• Report Number: 1018233-2025-10935
• Device Sequence Number: 9687326
• Product Code: KOD
• UDI-Device Identifier: 00801741171772
• UDI-Public: (01)00801741171772(11)250409(17)291228(10)MYKN5339
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K922431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 123614A
• Device Lot Number: MYKN5339
• 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: 11/28/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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: Required Intervention
• Patient Sex: Unknown