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

Catalog Number	919214A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2025
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: 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 there was a difficulty in removing the foley catheter balloon water.Four consecutive incidents occurred in which the balloon could not be removed after sterile distilled water was injected during pre-testing.Per follow up information received on 27oct2025, stated that all 4 incidents were from same batch# mykr3301 with different manufacturing lot#ngkn3120x3 and ngkn0583.
Additional Manufacturer Narrative
The reported event is confirmed via capa associated.This is addressed by capa 12474540.Received (16) photo samples.Three of the catheter photos are verified material 119314 and lot number ngkn3120.One of the catheter photos is verified material number 119314 and lot number ngkn0583.One of the photos shows an asymmetrical balloon might be due to inadequate inflation.Therefore, no new pr number needed.Functional testing was not possible based solely on these photos.Received 1 all silicone foley catheter with syringe.Verified material number 119314 and lot number ngk0583.Visual inspection noted balloon was inflated prior to testing.Water removed with a syringe.This sample was tested for "difficult to deflate." using the returned straight tup syringe, the catheter balloon was inflated with 10ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water).Inflated with no issues.Attempted to deflate balloon passively and only 2ml could be withdrawn within 5min.Using the in-house luer lock syringe, deflated balloon passively and successfully in 01min30sec, returning 10ml of solution.The complaint is against the syringe.Risk review, labeling review, and dhr review are not required as event has already been investigated per capa 12474540.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.
Event or Problem Description
It was reported that there was a difficulty in removing the foley catheter balloon water.Four consecutive incidents occurred in which the balloon could not be removed after sterile distilled water was injected during pretesting.Per follow up information received on 27oct2025, stated that all 4 incidents were from same batch mykr3301 with different manufacturing lot ngkn3120x3 and ngkn0583.

• 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: 23452713
• Report Number: 1018233-2025-09810
• Device Sequence Number: 15713555
• Product Code: MJC
• UDI-Device Identifier: 00801741040122
• UDI-Public: (01)00801741040122(17)270628(10)MYKR3301
• 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): 03/12/2026

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: 919214A
• Device Lot Number: MYKR3301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 03/13/2026
• 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