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

Catalog Number	806514
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2025
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.Udi format updated with available product information per gudid.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 foley catheter had a pin hole at the y connector.Saline was coming out.Lot#ngjw3118.Foley catheter balloon would not deflate lot#ngjt2607.Balloon would not deflate lot#ngjs5070.
Event or Problem Description
It was reported that foley catheter had a pin hole at the y connector.Saline was coming out.Lot#: ngjw3118.Foley catheter balloon would not deflate.Lot#: ngjt2607.Balloon would not deflate lot#: ngjs5070.Per customer via email on 04mar2025, it was reported that lot#: ngjw3118, item#: 806514 customers stated that the bard foley had a pinhole in it at the y connector.Saline came out.They went to test the foley securement, and it came out.Balloon was deflated.Lot# for the affected 2, 1 with balloon would not deflate.Lot#: ngjs5070.Or lot#: ngjt2607.Not sure what package either foley was pulled out of.The other one that customer did not know what was wrong with it was the 5070 lot.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.No actions can be taken at this time since a root cause was not identified.Visual evaluation of the returned sample noted three opened (without original packaging), used silicone foley.Visual inspection of the first sample noted using the (in-house) syringe attempted to inflate the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1 percentage aq methylene blue per 100ml distilled water) and observed a pin hole on the drainage funnel and the catheter shaft.This does not meet specification which states "missing, damaged, leaking, torn, broken, incomplete or incorrect components are not permitted, the clamp must be closed.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage silicone and may cause the balloon to burst.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local state, and federal laws and regulations.Cautions: federal (u.S.A) law restricts this device to sale by or on the order of a physician.Cautions: do not aspirate urine through drainage funnel wall.Storage: store catheter at room temperature away from direct exposure to light, preferably in the original box.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100 percentage silicone foley catheters.Sterile unless package is opened or damaged.Single patient use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.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 catheter-related adverse effect, the catheter should be replaced.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe stick in the valve.If you notice slow or no deflation, re- seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.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.Should balloon rupture occur, care should be taken to assure that all balloon fragments have been removed from the patient.Visually inspect the product for any imperfections or surface deterioration prior to use.Recommended inflation capacities.3cc balloon: use 5ml sterile water.5cc balloon: use 10cc sterile water.30cc balloon: use 35cc sterile water.Do not exceed recommended capacities.Correction: d, e, h.Udi format updated with available product information per gudid.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.

• Brand Name: BARDIA® 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 30014 ; 7707846100
• MDR Report Key: 21333374
• Report Number: 1018233-2025-00675
• Device Sequence Number: 15420246
• Product Code: GBM
• UDI-Device Identifier: 00801741039164
• UDI-Public: (01)00801741039164(11)241023(17)281130(10)NGJW3118
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K760093
• 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): 08/26/2025

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: 806514
• Device Lot Number: NGJW3118
• 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: 01/17/2025
• Supplement Date Received by Manufacturer: 08/26/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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