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

Model Number	802414
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/19/2020
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 urethral catheters were painful during insertion and withdrawal.Stated patient wondered if the eyelets were not polished like the ones got from his doctor¿s office.No medical intervention was reported.Per follow up on (b)(6) 2020, the patient experienced pain with insertion and removal of the catheter, but the pain was worse during removal.No medical intervention was required.The eyelets on the catheters did not feel as smooth previous catheters the customer had received.Patient noted that this only occured with the catheters from most recent order and used catheters from the previous order recently with same item, there were no issues.
Additional Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to "operator error." it was unknown whether the device had met specifications.The product used for the treatment purposes.It was unknown whether the product had caused the reported failure.The device was not returned for evaluation.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." 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.
Event or Problem Description
It was reported that the urethral catheters were painful during the insertion and withdrawal.It was stated the patient wonders whether the eyelets were not polished like the ones received from the doctor¿s office.No medical intervention was reported.Per follow-up on 20oct2020, the patient experienced pain during insertion and removal of the catheter, but the pain was worse during removal.No medical intervention was required.The eyelets on the catheters did not feel as smooth as previous catheters received by the customer.The patient noted that this only occurs with the catheters from the recent order and the used catheters from the previous order recently with the same item, there were no issues.

• Brand Name: BARDIA URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10817307
• Report Number: 1018233-2020-20856
• Device Sequence Number: 17174651
• Product Code: KOD
• UDI-Device Identifier: 00801741018350
• UDI-Public: (01)00801741018350
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2021

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: 802414
• Device Catalogue Number: 802414
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 02/09/2021
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 03/07/2021
• 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