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

Catalog Number	319214A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-test in the operating room, after injecting the foley catheter sterile water, water could not be removed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Initial reporter name: (b)(6).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 pretest in the operating room, after injecting the foley catheter sterile water, water could not be removed.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error.There is no allegation against a bd product but on a component in the tray.This report is being submitted as additional information.The reported event is confirmed other.Received (3) photo samples.Verified material number 119314.Received (3) photo samples.Verified material number 119314and lot number ngjy4783.Photo 2 shows asymmetrical balloon might be due to the inadequate inflation.Therefore, no new pr number needed.The condition of the affected catheter could not be confirmed because only photos were provided for the investigation.Functional testing was not possible based solely on these photos.Received a 3 way temp sensing catheter with cut portion of inlet tubing and a straight tipped syringe.Visual inspection noted that the balloon was inflated prior to the start of the evaluation.Deflated balloon passively using the returned syringe with no cuffing noted.This sample was tested for "difficult to deflate".Catheter balloon was inflated with 10ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water) and the catheter rested with no leaks noted.Attempted to deflate balloon passively using the returned syringe and only 3ml could be withdrawn.Using the inhouse luer lok syringe, deflated balloon in 01min35sec with no cuffing noted, returning 10ml of solution.The complaint is against the syringe.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.Based on the results of the investigation, no additional actions can be taken at this time.Corrections: d, f, h.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.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• 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: 23278728
• Report Number: 1018233-2025-09088
• Device Sequence Number: 15642069
• Product Code: MJC
• UDI-Device Identifier: 00801741040153
• UDI-Public: (01)00801741040153(11)241220(17)291219(10)NGJY4783
• 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): 03/05/2026

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: NGJY4783
• 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: 10/07/2025
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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