MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY; SILICONE FOLEY TRAY

Catalog Number	319214A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2025
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 during the pre-test, it became difficult to drain the water from foley catheter, and it became unusable.
Additional Manufacturer Narrative
The reported event is confirmed via capa associated.This is addressed by capa 12474540.Received 1 all silicone foley catheter with syringe.Verified material number 119314 and manufacturing lot number ngjx0304.Visual inspection noted no obvious observations.During testing, the catheter filled with 10ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) using returned syringe, the balloon inflated with no difficulty.Concentricity of catheter balloon is 89/11.Only 9 ml of methylene blue solution in the catheter balloon was deflated within 5 minutes.Again, the catheter was filled with 10 ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) using an in house syringe.The balloon deflated 10ml of solution within 02min09sec.This is out of specification per inspection procedure (b)(4) 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 reported event is confirmed against the returned syringe.Capa 12474540 identified the root cause of this failure as a combination of three (3) factors; provided water syringe does not meet user expectation for smooth engagement with the valve and no instructions are provided in the japanese ifu for aspirating to assist in deflation, deflation time or take off force criteria or specification to deflate the catheter has not been determined and it is unknown for the customers, inadequate process qualification performed with change in syringe supplier and mold change.Risk review, labeling review, and dhr review are not required as event has already been investigated per capa 12474540.Refer to capa 12474540 for further details.Correction: d, e, f, h.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 during the pretest, it became difficult to drain the water from foley catheter, and it became unusable.Per notification from investigator on 12jan2026, it was reported that asymmetrical balloon was found during sample evaluation on 15dec2025.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: SILICONE FOLEY TRAY
• 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: 22727583
• Report Number: 1018233-2025-06521
• Device Sequence Number: 15525800
• Product Code: MJC
• UDI-Device Identifier: 00801741040153
• UDI-Public: (01)00801741040153(11)241126(17)291120(10)NGJX0304
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K070582
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2026

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: Health Professional
• Device Catalogue Number: 319214A
• Device Lot Number: NGJX0304
• 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: 08/04/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 03/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2024
• 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