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

Model Number	806320
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Pain (1994); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	03/23/2021
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.
Event or Problem Description
It was reported that the foley catheter had ridges on it.Patient stated that it hurt during insertion and it caused bleeding while removing.No medical intervention was reported.
Event or Problem Description
It was reported that the foley catheter had ridges on it.Patient stated that it hurt during insertion and it caused bleeding while removing.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event is inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be due to "knifes without sharp/damaged edges and counter part of knife worn out".The device was used for treatment, though it was unknown if the device was related to the reported event or met specifications since a sample was not returned.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 were found adequate and state the following: "caution: federal (u.S.A.) law restricts this device to sale or on the order of a physician.Sterile: unless package is opened or damaged.Warning: 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 of sterile water 5 cc balloon: use 10ml of sterile water 30cc balloon: use 35ml of sterile water.Do not exceed recommended capacities.Warning: after use, this product may be a potential biohazard.Hand and dispose of in accordance with 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.Never use more force than is required to make the syringe "stick" in the valve.If you notice slow or no deflation, reseat 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 take to assure that all balloon fragments have been removed form the patient.Visually inspect the product for any imperfections or surface deterioration prior to use." h11: section a through f - 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.H3 other text : the device was not returned.

• Brand Name: BARDIA ALL-SILICONE FOLEY CATHETER
• Common Device Name: FOLEY CATHETER (SILICONE)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11682854
• Report Number: 1018233-2021-02164
• Device Sequence Number: 16931374
• Product Code: EZL
• UDI-Device Identifier: 00801741039133
• UDI-Public: (01)00801741039133
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: Lay User/Patient
• Device Model Number: 806320
• Device Catalogue Number: 806320
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other