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

Catalog Number	73016L
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The initial reporter phone number is (b)(6).The initial reporter fax is (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: 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 a 3v ch16 silicone urinary catheter reference 73016ce that developed a quality defect in customer's facility.The affected lot number was nggx4189.In practice, after insertion in the patient's home, the catheter developed a leak at the three-way separation.The catheter was removed and replaced with another catheter; another lot number was available at the department, with no apparent harm to the patient.The catheter was not retained; only the packaging was provided to them.
Additional Manufacturer Narrative
The initial reporter's phone number: (b)(6).The initial reporter's fax number: (b)(6).The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone.Visually inspect the product for any imperfections or surface deterioration prior to use.¿ use luer tip syringe to inflate.Note: aggressive traction, particularly in the presence of suturing, is not recommended for silicone foley catheters.To deflate catheter balloon: gently insert a luer slip tip syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.If necessary, contact adequately trained professional for assistance, as directed by hospital protocol.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d.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 a 3v ch16 silicone urinary catheter reference (b)(4) that developed a quality defect in customer's facility.The affected lot number was nggx4189.In practice, after insertion in the patient's home, the catheter developed a leak at the three-way separation.The catheter was removed and replaced with another catheter; another lot number was available at the department, with no apparent harm to the patient.The catheter was not retained; only the packaging was provided to them.

• Brand Name: BARDEX® LUBRI-SIL® 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: 23098441
• Report Number: 1018233-2025-08376
• Device Sequence Number: 18334378
• Product Code: EZL
• UDI-Device Identifier: 00801741034299
• UDI-Public: (01)00801741034299(11)221123(17)270429(10)NGGX4189
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K070558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2025

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: 73016L
• Device Lot Number: NGGX4189
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2025
• Supplement Date Received by Manufacturer: 12/16/2025
• Initial Report FDA Received Date: 09/19/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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