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	06/26/2025
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/eporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during pre-test the foley catheter sterile water did not drain.
Event or Problem Description
It was reported that during pre-test the foley catheter sterile water did not drain.Per notification from ucc on 17dec2025, it was reported that asymmetrical balloon was found during sample evaluation on 05nov2025.
Additional Manufacturer Narrative
The reported event is confirmed via capa associated.This is addressed by capa 12474540.Photo samples were submitted showing the catheter balloon inflated asymmetrically.Unable to confirm whether the catheter was fully inflated from the photos.The silicone foley catheter was returned with the syringe.Visual evaluation noted the catheter balloon was inflated and asymmetrical.The catheter balloon was inflated with 10ml methylene blue solution (mbs) using the returned syringe.The balloon inflated with no difficulty and was noted to inflated asymmetrically (100:0); this failure is documented and investigated via capa 11291030.An attempt was made to deflate the catheter balloon, however, only 5ml deflated in 5 minutes.The catheter balloon was then inflated with 10ml mbs using an in-house syringe, the balloon passively deflated in 01min52sec.The reported event is confirmed against the returned syringe.Capa 12474540 identified the root cause of this failure as a combination of three (3) factors; provided water syringe does not meet user expectation for smooth engagement with the valve and no instructions are provided in the japanese ifu for aspirating to assist in deflation, deflation time or take off force criteria or specification to deflate the catheter has not been determined and it is unknown for the customers, inadequate process qualification performed with change in syringe supplier and mold change.Risk review, labeling review, and dhr review are not required as event has already been investigated per capa 12474540, however, dhr review was completed prior to capa determination.Correction: d, 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: TEMPERATURE-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: 22438030
• Report Number: 1018233-2025-05644
• Device Sequence Number: 11545046
• Product Code: MJC
• UDI-Device Identifier: 00801741040122
• UDI-Public: (01)00801741040122(11)250220(17)270628(10)MYJZ4529
• 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): 12/18/2025

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: MYJZ4529
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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