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

Model Number	806520
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Sterile: unless package is opened or damaged.Warning: do not use ointments or lubricants having a petrolatum base.They will damage silicone and may cause balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Single use only.Do not reuse.Do not resterilize.For urological use only.Valve type: use luer slip syringe.Do not use needle.Recommended inflation capacities 3cc balloon: use 5ml sterile water 5cc balloon: use 10ml sterile water 30cc balloon: use 35ml sterile water do not exceed recommend capacities.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.Note: aggressive traction, particularly in the presence of suturing, is not recommended for 100% silicone foley catheters.To deflate catheter balloon: gently insert a syringe in the catheter valve.Ever use more force than is required to make the syringe "stick" in the valve.If you notice slow or now 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 professionals 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." (b)(4).The information provided by bard represents all of 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 bard.The device was not returned.
Event or Problem Description
It was reported that the catheter balloon failed to inflate upon pre-test of the catheter.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7357999
• Report Number: 1018233-2018-00910
• Device Sequence Number: 107080
• Product Code: EZL
• UDI-Device Identifier: 00801741039195
• UDI-Public: (01)00801741039195
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Home Health Aide
• Type of Report: Initial
• Report Date (Section B): 03/21/2018

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 Model Number: 806520
• Device Catalogue Number: 806520
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1