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	1758SI14
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2025
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 the syringe water injection was stiff, and the foley catheter bulges unevenly.
Event or Problem Description
It was reported that the syringe water injection was stiff and the foley catheter bulges unevenly.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Received (10) photo samples.The photo sample was returned and could not be evaluated for the reported failure.Visual evaluation of the returned sample noted two unopened (with original packaging), urological trays and two all silicone foley catheter with syringe 2758j14 and batch number ngjz2837.Catheter 1: visual inspection of the sample noted using the return syringe the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and observed a leak from a pin hole in the balloon measuring (0.013in).No resistance observed during the inflation process.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab d, h.Initial reporter complete facility name: (b)(6) hospital.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® 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: 23179864
• Report Number: 1018233-2025-08706
• Device Sequence Number: 15739873
• Product Code: MJC
• UDI-Device Identifier: 00801741032929
• UDI-Public: (01)00801741032929(11)250120(17)300113(10)NGJZ2837
• 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): 03/04/2026

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: 1758SI14
• Device Lot Number: NGJZ2837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 03/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/20/2025
• 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