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

Model Number	802412
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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 catheter had no eyelets, which restricted the flow.The patient alleged that he did not notice the device did not have eyelets until he inserted the device and no urine flowed, where he saw a small amount of blood.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Per evaluation, the red rubber intermittent catheter sample was examined and it was noted that the catheter was missing the drainage eyes.The root cause of this failure is operator error during the eye punching process due to which no eyes were punched, resulting in patient impact and no urine drainage.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿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.".
Event or Problem Description
It was reported that the catheter had no eyelets, which restricted the flow.The patient alleged that he did not notice the device did not have eyelets until he inserted the device and no urine flowed, where he saw a small amount of blood.

• Brand Name: BARDIA® URETHRAL CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8976485
• Report Number: 1018233-2019-05473
• Device Sequence Number: 276137
• Product Code: KOD
• UDI-Device Identifier: 00801741018343
• UDI-Public: (01)00801741018343
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 Expiration Date: 07/31/2022
• Device Model Number: 802412
• Device Catalogue Number: 802412
• Device Lot Number: NGDP0530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 11/29/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1