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

Model Number	802410
Medical Device Problem Code	Biocompatibility (2886)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	03/23/2021
Type of Reportable Event	Serious Injury
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 patient had urinary tract infection and although there was no allegation against the product.Historically, the patient was provided with the touchless plus catheter.But as per the sample received on (b)(6) 20201, the touchless plus unisex catheter was not returned, instead the customer returned bardia urethral red rubber catheters.It was unknown whether medical intervention was provided.
Additional Manufacturer Narrative
The reported event was inconclusive due to lack of information.90 unopened red rubber urethral catheters were returned in original packaging.13 catheters were selected according to sampling plan.As urinary tract infection can be caused by no drainage due to the catheter having no drainage eye, the catheters were inspected for drainage eyes.All 13 catheters were noted to have drainage eyes.Using a di water fountain, di water was attempted to be passed through the drainage lumen of the 13 catheters.Water was able to be passed through all 13 catheters with no occlusions noted.As the patient¿s anatomy was unknown, unable to determine if the product led to a urinary tract infection (uti), therefore the reported event is inconclusive.A potential root cause for this failure could be patient sensitivity to materials.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: "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." correction: h.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 actual/suspected device was inspected.
Event or Problem Description
It was reported that the patient had urinary tract infection and although there was no allegation against the product.Historically, the patient was provided with the touchless plus catheter.Per sample received on 23mar2020, it was noted that a bardia urethral red rubber catheter was received for evaluation.It was unknown whether medical intervention was provided.

• Brand Name: BARDIA® URETHRAL CATHETER
• Common Device Name: URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 11689433
• Report Number: 1018233-2021-02191
• Device Sequence Number: 3073363
• Product Code: KOD
• UDI-Device Identifier: 00801741018336
• UDI-Public: (01)00801741018336
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/03/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 12/31/2024
• Device Model Number: 802410
• Device Catalogue Number: 802410
• Device Lot Number: NGEX4975
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/23/2021
• Supplement Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 04/19/2021
• Supplement Report FDA Received Date: 12/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female