MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® URETHRAL CATHETER; BARDIA URETHRAL CATHETER

Model Number	802416
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pain (1994); 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 was unable to insert the catheter and experienced considerable pain and bleeding.The patient was reportedly taken to the emergency room; treatment provided is unknown.
Event or Problem Description
It was reported that the patient was unable to insert the catheter and experienced considerable pain and bleeding.The patient was reportedly taken to the emergency room; treatment provided is unknown.Per additional information received from the customer contact on jul 26 2019, the patient was taken to the emergency room to have a new catheter inserted.There was no medical intervention performed.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause could be ¿outside diameter is too large¿ which resulted in tissue irritation upon insertion that lead to patient experience pain and bleeding.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: "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" corrections: b1, b2, h1.H11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: BARDIA® URETHRAL CATHETER
• Common Device Name: BARDIA URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8811533
• Report Number: 1018233-2019-04097
• Device Sequence Number: 2657650
• Product Code: KOD
• UDI-Device Identifier: 00801741018367
• UDI-Public: (01)00801741018367
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 802416
• Device Catalogue Number: 802416
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/02/2019
• 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