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

Catalog Number	010114
Medical Device Problem Code	Material Invagination (1336)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient used bard red rubber catheter 010114, shipped to them from the va medical center in a 90-day supply.They stated that their recent shipment of catheters were different than the previous shipment.Lot# mgjr3584 had a different color to them, more orangish; they were firmer and more bulbus at the tip causing discomfort when used.Also stated that this lot also had a different stamp on them and were made in malaysia.They stated that the previous catheters were softer.They had additional lots ngjn2942 and ngjp1135 as well.Representative advised bd's manufacturing procedures were standardized across plants and were based upon the specific product being made.They provided product numbers for hydrophilic intermittent catheters (120612, 50612, and rtu12c) to request samples from the va.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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.
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was available for evaluation and further investigation did not result in any additional findings.The device history record review could not be performed without a lot number.No actions can be taken at this time since a root cause was not identified.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: wash your hands thoroughly with soap and water.Remove catheter from the pack.Position yourself comfortably, cleaning the opening of the urethra and surrounding area.Gently insert rounded end of catheter into urethra.When urine stops flowing, remove catheter from urethra.Dispose of catheter in accordance with local rules and regulations.Wash your hands.Udi format updated with available product information per gudid.H11: section a through f - the information provided by bd represents all 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.
Event or Problem Description
It was reported that the patient used bard red rubber catheter 010114, shipped to them from the va medical center in a 90-day supply.They stated that their recent shipment of catheters were different than the previous shipment.Lot# mgjr3584 had a different color to them, more orangish; they were firmer and more bulbus at the tip causing discomfort when used.Also stated that this lot also had a different stamp on them and were made in malaysia.They stated that the previous catheters were softer.They had additional lots ngjn2942 & ngjp1135 as well.Representative advised bd's manufacturing procedures were standardized across plants and were based upon the specific product being made.They provided product numbers for hydrophilic intermittent catheters (120612, 50612, and rtu12c) to request samples from the va.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 20310133
• Report Number: 1018233-2024-06051
• Device Sequence Number: 21049446
• Product Code: KOD
• UDI-Device Identifier: 00801741029868
• UDI-Public: (01)00801741029868
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 01/07/2025

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 Catalogue Number: 010114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 01/08/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Unknown