MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING FOLEY CATHETER

Catalog Number	119316M
Medical Device Problem Codes	Material Puncture/Hole (1504); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported from (b)(6) has stated an issue with a319516am.No known lot # due to the package contents being thrown away.No known harm to the patient reported.The registered nurse had placed the foley for a patient who was having spine surgery.At the end of the surgery when they went to flip the patient, the foley had come out and the balloon was deflated.They inserted a syringe to try and inflate the balloon to see if it was defective.It inflated, but then immediately deflated.There was a hole in the balloon.
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 from the hospital user has stated an issue with a319516am.No known lot number due to the package contents being thrown away.No known harm to the patient reported.The registered nurse had placed the foley for a patient who was having spine surgery.At the end of the surgery when they went to flip the patient, the foley had come out and the balloon was deflated.They inserted a syringe to try and inflate the balloon to see if it was defective.It inflated, but then immediately deflated.There was a hole in the balloon.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 11092653.Received 1 drainage bag with an inlet tube with sample port connector, catheter, and syringe.Visual inspection noted no obvious observations.During the testing, the catheter balloon was inflated with 10ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water), and immediately lumen to lumen leakage was present.This is out of specification per instruction procedure which states "catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloons are not allowed, and must inflate and deflate with the use of a syringe." risk review, labeling review, and dhr review are not required as event has already been investigated per capa 11092653.Corrections: d, f, h udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE TEMP SENSING 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: 23497152
• Report Number: 1018233-2025-10059
• Device Sequence Number: 21060579
• Product Code: MJC
• UDI-Device Identifier: 00801741039911
• UDI-Public: (01)00801741039911(11)250805(17)300724(10)NGKT4251
• Combination Product (Y/N): Y
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2026

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: Lay User/Patient
• Device Catalogue Number: 119316M
• Device Lot Number: NGKT4251
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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: Other
• Patient Sex: Unknown