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

Catalog Number	319216A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sterile water did not drain from the foley catheter during pre-test.
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 sterile water did not drain from the foley catheter during pre-test.Per notification from ucc on 08dec2025, it was reported that asymmetrical balloon was found during sample evaluation on 30sep2025.Per notification from ucc on 08dec2025, it was reported that difficult to deflate issue against the returned syringe was found during evaluation on 30sep2025.
Additional Manufacturer Narrative
The reported event was confirmed- other.Received (3) photo samples.The photo sample was returned and could not be evaluated for the reported failure.The material number for sample return is different from the material number reported.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with return syringe.Visual inspection of the sample noted using the return syringe, inflated balloon with 10 ml of solution using the and the catheter rested with no leaks noted.The balloon was asymmetrical.Attempted to deflate balloon passively and only 4ml deflated within 5min could be withdrawn using the return syringe.Using the (in-house) luer lock syringe, deflated balloon 10ml passively within 01min36sec.The reported event is confirmed against the returned syringe.The labeling is found to be adequate.The device history record review could not be performed without a lot number.Based on the results of the investigation, no additional actions are required at this time.Corrections: d, e, 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 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: 21960551
• Report Number: 1018233-2025-03239
• Device Sequence Number: 9252867
• Product Code: MJC
• UDI-Device Identifier: 00801741040160
• UDI-Public: (01)00801741040160
• 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): 01/23/2026

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: 319216A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 01/23/2026
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 01/26/2026
• 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