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

Catalog Number	319214A
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2025
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: 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.
Event or Problem Description
It was reported that when a pre-test was conducted in the operating room to place a foley catheter for urinary catheterization and temperature control, it was found that sterile water could not be injected.
Additional Manufacturer Narrative
The reported event was unconfirmed.Five (5) photos were received for evaluation.The first photo was of the top view of the catheter and return syringe.The second photo was a zoomed in view of the trifurcation site.The third photo was a zoomed in view of the tip of the catheter with deflated balloon.The fourth photo was of the inflation cap with the batch # ngjw2610.The last photo was of the tray labeling with the batch # myjz4526.Received 1 all-silicone temp sensing foley catheter with sample port connector, syringe and packaging label.Verified material number 119314, batch number myjz4526 and manufacturing lot number ngjw2610.Visual inspection noted no obvious observations.Using the returned syringe, the catheter balloon was inflated with 10 ml 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water) and the catheter rested with no leaks noted.Attempted to deflate balloon passively and only four (4) ml could be withdrawn with the returned syringe.Using the in-house luer lock syringe, deflated balloon passively in under two (2) minutes with no cuffing or leaks noted, returning 10ml of solution.Risk, labelling, and dhr review is not required as reported event was unconfirmed.Corrections made to tab(s) d and h.Initial reporter complete facility name: (b)(6) hospital.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 when a pre-test was conducted in the operating room to place a foley catheter for urinary catheterization and temperature control, it was found that sterile water could not be injected.Per notification from ucc on 17dec2025, it was reported that difficult to deflate with the returned syringe was found during sample evaluation on (b)(6) 2025.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Common Device Name: 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: 22329118
• Report Number: 1018233-2025-05048
• Device Sequence Number: 15848618
• Product Code: MJC
• UDI-Device Identifier: 00801741040153
• UDI-Public: (01)00801741040153
• 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): 03/09/2026

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
• 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: 06/23/2025
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 03/11/2026
• 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