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

Catalog Number	1857SI22
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
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.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 the customer has seen a few 22fr open tip catheters # 1857si22 being occluded, meaning the opening of the catheter was blocked and because of it, they had to replace the catheter on a few patients after being inserted in the operating room.
Event or Problem Description
It was reported that the customer has seen a few 22fr open tip catheters 1857si22 being occluded, meaning the opening of the catheter was blocked and because of it, they had to replace the catheter on a few patients after being inserted in the operating room.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.Product labeling was reviewed for this investigation.The reported event is addressed within the labeling as it states: "do not use if package is opened or damaged.Warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheterrelated adverse effect, the catheter should be replaced.To deflate catheter balloon: gently insert a luer slip 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 permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol." a dhr could not be performed since no lot number was provided.Correction: 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® I.C. 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: 23513230
• Report Number: 1018233-2025-10133
• Device Sequence Number: 9877269
• Product Code: MJC
• UDI-Device Identifier: 00801741017360
• UDI-Public: (01)00801741017360
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2026

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: 1857SI22
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 03/03/2026
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 03/05/2026
• 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