MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY; TEMP-SENSING URINE METER 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	09/08/2025
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.All available udi information is being provided.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 foley catheter cuff test, the sterile distilled water did not drain.
Event or Problem Description
It was reported that during the foley catheter cuff test, the sterile distilled water did not drain.
Additional Manufacturer Narrative
Corrections: d, h.The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 foley catheter cuff test, the sterile distilled water did not drain.Per notification from investigator on 12feb2026, it was reported that the asymmetrical balloon was found during sample evaluation on 24dec2025.
Additional Manufacturer Narrative
This supplemental mdr is being submitted to capture additional information from follow up and the investigation details.There was no patient involvement.This event is not reportable.The reported event is confirmed - other.Photo: received four (4) photo samples.All photo samples showcase an overview of an all-silicone foley catheter and its packaging.Visual: received one (1) used all-silicone foley catheter with syringe without original packaging.Verified material number 119314 and manufacturing lot number ngjy4779.Visual inspection noted no obvious observations.Using the returned syringe, the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.Attempted to deflate balloon passively and only seven (7) ml could be withdrawn with the returned syringe.Asymmetrical balloon observed, formula ((1.5 / (1.5 + 0.5)) * 100, ballon concentricity= 75/25.Using the in-house luer lock syringe, deflated balloon passively in under one (1) minute with no cuffing or leaks noted, returning 10ml of solution.The complaint is against the syringe.Labelling and instructions for use were reviewed for this investigation.The labeling is found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Correction: 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.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: TEMP-SENSING URINE METER 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: 23066579
• Report Number: 1018233-2025-08194
• Device Sequence Number: 9866976
• Product Code: MJC
• UDI-Device Identifier: 00801741040153
• UDI-Public: (01)00801741040153(11)250605(17)270628(10)MYKR1704
• 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,Followup
• Report Date (Section B): 02/19/2026

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: MYKR1704
• 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: 09/09/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 02/19/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/10/2025; 02/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2025
• 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