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

Catalog Number	1758SI20
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2025
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: 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 use, they discovered a sterile water leak near the funnel of the foley catheter.Leak near the funnel.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 12182448.Photo sample evaluation: visual evaluation of the returned 4 photo sample noted one opened (without original packaging), used silicone foley with syringe.Visual inspection of the first photo sample noted shows two way foley catheter with syringe.The second photo show small tear with a direction near the inflation valve.The third photo sample show the inflation valve and cap with material 2758j20 and manufacturing lot number ngjw0146.The condition of the affected catheter could not be confirmed from the photos provided.Functional testing was not possible based solely on these photos.Visual: received 1 all silicone foley catheter with syringe.Verified material number 2758j20 and manufacturing lot number ngjw0146.Visual inspection noted no obvious observations.The catheter balloon was inflated with 10ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water) using returned syringe.However, there is a pinhole at trifurcation site measuring 0.015in.This is out of specification per inspection procedure 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." visual update: parent photo 2 shows an arrow pointing to maybe a pinhole below the inflation cap, but per physical sample received and evaluation, that area has no defect and no leak noted.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.Corrections: d, f, h.This report references a us equivalent device.The us udi equivalent for this product number is used.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 use, they discovered a sterile water leak near the funnel of the foley catheter.Leak near the funnel.

• Brand Name: BARDEX® LUBRI-SIL® I.C. ALL-SILICONE FOLEY CATHETER
• Common Device Name: 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: 23110345
• Report Number: 1018233-2025-08425
• Device Sequence Number: 21201328
• Product Code: EZL
• UDI-Device Identifier: 00801741025242
• UDI-Public: (01)00801741025242(11)240927(17)290919(10)NGJW0146
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040504
• 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): 04/06/2026

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: 1758SI20
• Device Lot Number: NGJW0146
• 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: 09/18/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 04/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2024
• 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