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

Catalog Number	1758SI12
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name: (b)(6).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 inflation lumen and drainage lumen were penetrated when sterile water was injected.Per follow up information received via ibc on 02dec2025, stated that they were unknown about any cut or pinhole in the lumen area.
Event or Problem Description
It was reported that the inflation lumen and drainage lumen were penetrated when sterile water was injected.Per follow up information received via ibc on 02dec2025, stated that they were unknown about any cut or pinhole in the lumen area.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation: visual evaluation of the returned five-photo sample noted one opened (without original packaging), used silicone foley.Visual inspection of the first photo sample noted shows the biohazard plastic bag with n 44121519 written over it.The second photo shows the overview temp sensing foley catheter with sample port connector and syringe.The third photo sample show the overview of the foley catheter bifurcation site.The fourth photo shows the overview of the foley catheter tip and drainage eye.The fifth photo shows the inflation valve/cap with manufacturing lot number ngjs1021.This does not meet specification which states "catheter leaks, valve leaks, balloon perforation, lumen to lumen, prematurely deflated and dislodged balloons are not allowed, and must inflate and deflate with the use of a syringe." product labeling was reviewed for this investigation.The reported event is addressed within the labeling as it states: contraindications: be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] directions for use: carefully insert the catheter into the urethral meatus.After the balloon advanced in the bladder, attach the needleless syringe, and gently infuse the specified volume of sterile water to inflate the balloon.Precautions for use: insert catheter into the urethral meatus, and advance it until the balloon enters the bladder and urine flows out through the catheter.Using a syringe packaged in the tray, infuse the specified volume of sterile water into the inflation lumen to inflate the balloon.When resistance is encountered in inserting catheter, stop the procedure and remove the catheter.When deflating balloon, do not aspirate with a syringe by hands.[the inflation lumen for balloon deflation may be occluded by negative pressure, and as a result the catheter cannot be removed.].A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Initial reporter name: (b)(6) hospital, (b)(6).Correction: f, h.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.
Additional Manufacturer Narrative
The reported event is confirmed manufacturing related.This is addressed by capa 11092653.Visual evaluation noted received 1 all silicone foley catheter and syringe.Using returned solution attempted to inflate with 10 ml methylene blue solution (3 drops 1 percent aq methylene blue per 100ml distilled water) but solution immediately leaked to the drainage funnel indicating lumen to lumen leak.Based on the physical sample received the reported event is confirmed manufacturing related and does not meet specifications 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 possible root causes for this failure, per capa 11092653, are "funnel wall thickness to thin due to molding core pin shape" or "extruded tube diameter with variation causing leak in catheter funnel molding." risk review, labeling review, and dhr review are not required as event has already been investigated per capa 11092653.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 the inflation lumen and drainage lumen were penetrated when sterile water was injected.Per follow up information received via ibc on 02dec2025, stated that they were unknown about any cut or pinhole in the lumen area.

• 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: 23728002
• Report Number: 1018233-2025-10820
• Device Sequence Number: 10231939
• Product Code: MJC
• UDI-Device Identifier: 00801741025204
• UDI-Public: (01)00801741025204(11)240730(17)290725(10)NGJS1021
• 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,Followup
• Report Date (Section B): 03/26/2026

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: 1758SI12
• Device Lot Number: NGJS1021
• 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: 11/26/2025
• Supplement Date Received by Manufacturer: 03/03/2026; 03/26/2026
• Initial Report FDA Received Date: 12/05/2025
• Supplement Report FDA Received Date: 03/04/2026; 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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