MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER; COUDE INTERMITTENT CATHETER

Model Number	802512
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
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.The device was not returned.
Event or Problem Description
It was reported that the patient stated the catheter alignment was not correct, it would not insert right and was difficult to insert.Also stated in the past, patient had catheters where coude tip was not perfectly a 45 degree angle.Stated this caused patient bleeding.No medical intervention was reported.
Additional Manufacturer Narrative
The reported event was unconfirmed since the product meets specifications stating that "accept any curve unless catheter is completely straight".The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "instructions for use indications for use: for urological use only.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Caution: this product contains natural rubber latex which may cause allergic reactions.Warnings: ¿ on latex and red rubber catheters, do not use ointments or lubricants having a petrolatum base.They will damage latex.¿ visually inspect the product for any imperfections or surface deterioration prior to use.¿ reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to failure, and/or to injury, illness or death of the patient.Note: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Adverse reactions urinary tract infection bleeding from the urethra irritation of the urethra instructions for intermittent catheters: 1.Wash your hands thoroughly with soap and water.2.Remove catheter from the pack.3.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.4.Gently insert rounded end of catheter into urethra.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.Caution: federal (u.S.A.) laws restricts this device to sale by or on the order of a physician.".
Event or Problem Description
It was reported that the patient stated the catheter alignment was not correct, it would not insert right and was difficult to insert.Also stated in the past, patient had catheters where coude tip was not perfectly a 45 degree angle.Stated this caused patient bleeding.No medical intervention was reported.

• Brand Name: BARDIA COUDE OLIVE TIP URETHRAL FOLEY CATHETER
• Common Device Name: COUDE INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10482455
• Report Number: 1018233-2020-05630
• Device Sequence Number: 14429132
• Product Code: KOD
• UDI-Device Identifier: 00801741039034
• UDI-Public: (01)00801741039034
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2020

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: 802512
• Device Catalogue Number: 802512
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/11/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1