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	03/24/2025
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.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 during the pre-test, in the foley catheter, one side was bulged at a ratio of 9:1 and there was also garbage in the tray.Per sample evaluation received on 24mar2025, during sample evaluation the syringe had difficulty to deflate was found.Per sample evaluation received on 24mar2025, during sample evaluation cuffing was found.
Event or Problem Description
It was reported that during the pre-test, in the foley catheter, one side was bulged at a ratio of 9:1 and there was also garbage in the tray.Per sample evaluation received on 24mar2025, during sample evaluation the syringe had difficulty to deflate was found.Per sample evaluation received on 24mar2025, during sample evaluation cuffing was found.
Additional Manufacturer Narrative
The reported event was confirmed.Photo: received seven (7) photo samples.All photo samples showcase an overview of all-silicone temp sensing foley catheter tray and its packaging.Visual: received one (1) all-silicone temp sensing foley catheter tray.Visual inspection noted foreign material inside the tray.Using the returned syringe, the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and the balloon concentricity was observed to be 100:0 as compared to attachment 1.The balloon did not passively deflate in under five (5) minutes.Using the in-house luer lock syringe, deflated balloon passively in under four (4) minutes with no leaks noted, returning 10ml of solution.However, cuffing was observed.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling for this investigation.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.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: 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: 21815514
• Report Number: 1018233-2025-02539
• Device Sequence Number: 15275802
• Product Code: MJC
• UDI-Device Identifier: 00801741040122
• UDI-Public: (01)00801741040122(11)240723(17)270428(10)MYJT3764
• 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): 01/08/2026

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: MYJT3764
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 01/08/2026
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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