MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER TRAY; FOLEY TRAY

Catalog Number	900114A
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
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 when the inflation was checked before placement on the patient, foley catheter balloon was fully inflated on only one side.Per investigator's notification received on 25mar2025, it was reported that difficult to deflate due to returned syringe was found during sample evaluation.
Additional Manufacturer Narrative
The reported event was confirmed.Photo: received four (4) photo samples.All photo samples showcase an overview of an all-silicone foley catheter and its packaging.Visual: received one (1) used all-silicone foley catheter with syringe without original packaging.Visual inspection noted no obvious observations.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 of tm0300903 (rev 3).Attempted to deflate balloon passively, however did not deflate under five (5) minutes.Using the in-house luer lock syringe, deflated balloon passively in under three (3) minutes with no cuffing or leaks noted, returning 10ml of solution.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.Based on the results of the investigation, no additional actions can be taken at this time.Initial reporter name: (b)(6).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 the inflation was checked before placement on the patient, foley catheter balloon was fully inflated on only one side.Per investigator's notification received on 25mar2025, it was reported that difficult to deflate due to returned syringe was found during sample evaluation.

• Brand Name: LUBRI-SIL® I.C. COMPLETE CARE® ALL-SILICONE FOLEY CATHETER 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: 21832609
• Report Number: 1018233-2025-02602
• Device Sequence Number: 19880061
• Product Code: MJC
• UDI-Device Identifier: 00801741032929
• UDI-Public: (01)00801741032929(11)240523(17)270428(10)MYJR3086
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K984136
• 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): 01/20/2026

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: 900114A
• Device Lot Number: MYJR3086
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2025
• Supplement Date Received by Manufacturer: 01/20/2026
• Initial Report FDA Received Date: 04/14/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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