MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; COUDE INTERMITTENT CATHETER

Model Number	010118
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Codes	Irritability (2421); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/08/2022
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 patient had a difficulty in inserting the intermittent catheter.It caused a rough spot and a small amount of bleeding.No medical intervention was reported.Per additional information via form with sample returned on 01mar2022, it was reported that the catheter could not be inserted beyond a few inches.Original bard olive tip catheter were discontinued, and initial replacement was not liked and currently patient had a proper product.
Additional Manufacturer Narrative
The reported event was unconfirmed because the device meets specifications.The lot samples returned by the customer were unused.However, the reported product was used for treatment purposes.The product had not caused the reported failure.No root cause could be found because the reported event was unconfirmed.A dhr review is not required as the event is unconfirmed.As the reported event is unconfirmed a labeling review is not required.Corrections: g.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 evaluated.
Event or Problem Description
It was reported that the patient had a difficulty in inserting the intermittent catheter.It caused a rough spot and a small amount of bleeding.No medical intervention was reported.Per additional information via form with sample returned on 01mar2022, it was reported that catheter could not insert beyond a few inches.Original bard olive tip catheter were discontinued and initial replacement was not liked by patient and currently they had proper product.
Event or Problem Description
It was reported that the patient had a difficulty in inserting the intermittent catheter.It caused a rough spot and a small amount of bleeding.No medical intervention was reported.Per additional information via form with sample returned on (b)(6) 2022, it was reported that catheter could not insert beyond a few inches.Original bard olive tip catheter were discontinued and initial replacement was not liked by patient and currently they had proper product.
Additional Manufacturer Narrative
The reported event is inconclusive due to lack of information.11 orange coude tip catheters were returned unopened in original packaging.Catheters were visually observed and no lumps or flashing was noted, meeting specification.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Based on the results of the investigation no additional action is required at this time.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." "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: g 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.The actual/suspected device was evaluated.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE INTERMITTENT 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13693029
• Report Number: 1018233-2022-01109
• Device Sequence Number: 5046483
• Product Code: KOD
• UDI-Device Identifier: 00801741029882
• UDI-Public: (01)00801741029882
• 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,Followup
• Report Date (Section B): 07/05/2022

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: 05/31/2026
• Device Model Number: 010118
• Device Catalogue Number: 010118
• Device Lot Number: NGFX1346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/08/2022
• Supplement Date Received by Manufacturer: 06/13/2022; 07/06/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 06/15/2022; 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2021
• 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 Age: 62 YR
• Patient Sex: Male
• Patient Weight: 104 KG