MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER

Catalog Number	119316
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pretest the foley catheter sterile water leaked from the funnel.
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: 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 during pretest the foley catheter sterile water leaked from the funnel.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 12182448.Visual evaluation of the four photo samples noted one opened (without original packaging) used silicone foley catheter with syringe.Visual inspection of the first photo sample shows the biohazard plastic bag with r 44120458 written over it.The second photo shows an overview of the silicone foley catheter with a cut portion of the inlet tube, the tamper evident seal, and the syringe.The third photo sample shows an enlarged image of the silicone foley trifurcation site with a highlighted arrow pointing.The fourth photo shows the inflation valve/cap with material number 119316 and manufacturing lot number ngjx0481.The condition of the affected catheter could not be confirmed from the photos provided.Functional testing was not possible based solely on these photos.Received 1 all-silicone temp sensing foley catheter with sample port connector and syringe.Visual inspection noted no obvious observations.During testing, catheter filled with 10ml of methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), using returned syringe.Upon inflation leakage was observed in pin hole at trifurcation site measuring 0.013in.This is out of specification per inspection procedure ip7603444, revision 0, which states, catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloon are not allowed, and must inflate and deflate with the use of a syringe.The root cause for this failure, per capa 12182448, is the silicone injected into the forming cavity is entering pre-cured, which causes overheating in the gate area or injection point, as a result, the breaking point between the gate and the molded part is not properly generated, which prevents automatic separation.This requires manual detachment, increasing the risk of perforation at the adapter injection point due to the high temperature in the gate caused by the lack of flow in the jacket.Risk review, labeling review, and dhr review are not required as event has already being investigated per capa 12182448.Refer to capa 12182448 for further details.Correction: d, f, h.Udi format updated with available product information per gudid.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.

• Brand Name: BARDEX® LUBRI-SIL® I.C. TEMPERATURE-SENSING ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• 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: 23615920
• Report Number: 1018233-2025-10418
• Device Sequence Number: 21077138
• Product Code: MJC
• UDI-Device Identifier: 00801741039850
• UDI-Public: (01)00801741039850(11)241113(17)291107(10)NGJX0481
• 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): 03/19/2026

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: 119316
• Device Lot Number: NGJX0481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 03/19/2026
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 03/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/13/2024
• 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