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

Catalog Number	119314M
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	05/15/2025
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 that foley catheter was removed from patient in medical intensive care unit rm 4.The balloon did not deflate completely when aspirated the fluid.They pulled the catheter from the patient, and it caused them some discomfort.When it came out, they checked the catheter, and it looked like the picture below when it came out.It slowly deflated after maybe 1 to 2 minutes.Infused some water again to see if it would inflate and it did, however it would not deflate even with strong pull from the syringe plunger.They placed the foley in red bio-hazard bag and placed it on top of the supply cart.No medical intervention was reported.
Event or Problem Description
It was reported that foley catheter was removed from patient in medical intensive care unit rm 4.The balloon did not deflate completely when aspirated the fluid.They pulled the catheter from the patient, and it caused them some discomfort.When it came out, they checked the catheter, and it looked like the picture below when it came out.It slowly deflated after maybe 1 to 2 minutes.Infused some water again to see if it would inflate and it did, however it would not deflate even with strong pull from the syringe plunger.They placed the foley in red bio-hazard bag and placed it on top of the supply cart.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned photo sample noted one opened (without original packaging), used silicone foley with cut inlet tubing.Visual inspection of the sample noted that the catheter balloon was partially inflated.This does not meet specification which states catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.The device history record review could not be performed without a lot number.The instructions for use were found adequate and state the following: intended for use in the drainage and/or collection and/or measurement of urine.Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder.However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract.Sterile unless package is opened or damaged, except for any individually packaged components within the tray which are not labeled as sterile.These components are not terminally sterilized.Warning: do not use if allergic to iodine.For urological use only.Warning: on catheter, do not use ointments or lubricants having a petrolatum base, they wil damage silicone and may cause balloon to burst correction: h 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® 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: 22124676
• Report Number: 1018233-2025-04105
• Device Sequence Number: 15324376
• Product Code: MJC
• UDI-Device Identifier: 00801741039904
• UDI-Public: (01)00801741039904
• Combination Product (Y/N): Y
• Initial Reporter State: FL
• 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): 08/19/2025

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: 119314M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Supplement Date Received by Manufacturer: 08/19/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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