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

Catalog Number	038008
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the while attempting to inject dye into cone tip catheter, the syringe was not able to connect.The doctor informed the adapter needs to be ordered.Representative advised the cone tip nor olive tip ureteral catheter are sold with an adapter.Provided plastic adapter product number (140000).
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 since no sample was return for evaluation.A potential root cause for this failure mode could be ¿incorrect hub / luer design".The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "bard® reusable woven ureteral catheters manual cleaning and disinfection instructions these devices are supplied sterile and must be cleaned, disinfected, and visually examined prior to each subsequent use.Steam sterilization is not recommended for these devices.Caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.Prior to cleaning: use personal protective equipment (e.G.Gloves, gowns, eyewear, face masks or shields, respiratory protection devices) appropriately to protect users from exposure to both chemicals and microorganisms.After use, devices may be a potential biohazard.Handle in accordance with accepted medical practice and applicable local, state, and federal laws and regulations.Between uses, devices should be cleaned manually (includes presoak, rinsing, brushing, and drying), visually examined, and disinfected per the instructions below.Special instructions for 3 fr and 4 fr ureteral catheters: due to the fragile lumen wall, using a syringe with a needle on the 3 fr and 4 fr ureteral catheters is not recommended.Two compatible tuohy borst adapters and luer lock syringes will be required: one for cleaning and one for disinfecting the 3 fr and 4 fr ureteral catheters.Discard the tuohy borst adapters after the cleaning and disinfecting procedures.For more information regarding this type of adapter, call c.R.Bard, inc.Medical services and support at 1-800-227-3357 or email medical.Services@crbard.Com.Manual cleaning: ¿ timing ¿ clean medical devices as soon as practical after use (e.G.At the point of use), because soiled materials become dried or baked on devices making the removal process more difficult.¿ point of use pre-cleaning ¿ remove metal stylet from catheter, if applicable.For flushing the 3 fr and 4 fr ureteral catheters: use a compatible tuohy borst adapter and luer lock syringe to remove excess soil with a liquid flush from the proximal end using cool tap water (maximum 25°c, 77°f).E yelets near the tip shall also be flushed with the tuohy borst adapter and luer lock syringe.The eyelets should be advanced far enough into the adapter to ensure all eyelets are flushed.For all other french sizes: use appropriately sized syringe to remove excess soil with a liquid flush from the proximal end using cool tap water (maximum 25°c, 77°f).Eyelets near the tip shall also be flushed with this syringe.After flushing, brush device for a minimum of one (1) minute with a clean, soft bristle brush of an appropriate size.¿ cleaning ¿ detergent solution preparation - prepare and use an enzymatic detergent solution according to manufacturer¿s instructions.Enzol¿ enzymatic detergent also known as cidezyme¿ enzymatic detergent was validated with these devices using 1 oz per gallon of warm tap water 27°c to 44°c (81°f to 111°f).If using an equivalent enzymatic detergent solution, refer to manufacturer¿s instructions for dilution and water temperatures.Water temperature should not exceed 45°c (113°f for any step of this cleaning process.Presoak and flush - completely immerse devices in the enzymatic detergent solution for a minimum of one (1) minute.While immersed, manipulate devices and use a syringe of an appropriate size to flush detergent solution through the entire length of the lumen.Actuate devices while immersed in the detergent solution to ensure all hard to reach areas are contacted by the detergent solution.For flushing the 3 fr and 4 fr ureteral catheters, use a compatible tuohy borst adapter and luer lock syringe as previously mentioned.Brush ¿ after soaking, use a clean, soft bristle brush of an appropriate size to clean all external surfaces.Flush ¿ for 3 fr and 4 fr ureteral catheters, use a compatible tuohy borst adapter and luer lock syringe to flush the inner lumen with a minimum of 15 ml of detergent solution.Actuate devices while flushing.For all other french sizes, flush devices with a minimum of 50 ml of detergent solution.Actuate devices while flushing.Use a syringe of an appropriate size and diameter.Repeat the flush process two (2) times for a total of three (3) flushes, ensuring all visible soil and debris is removed and all fluid exiting the lumen is clear.If visible soil is detected during the final lumen flush, repeat brushing and flushing steps.Rinsing - step 1: rinse devices thoroughly under running water (sterile or distilled) with a temperature range of 27°c to 44°c (81°f to 111°f) for a minimum of two (2) minutes to remove any residual detergent solution or debris.Step 2: flush ¿ for 3 fr and 4 fr ureteral catheters, flush the inner lumen with a minimum of 15 ml of sterile or distilled water utilizing a temperature range of 27°c to 44°c (81°f to 111°f) using a compatible tuohy borst adapter and luer lock syringe.For all other french sizes, flush the inner lumen with 50 ml of sterile or distilled water utilizing a temperature range of 27°c to 44°c (81°f to 111°f).Use a syringe of an appropriate size and diameter.Step 3: brush - use a clean, soft bristle brush of an appropriate size to brush devices for a minimum of one (1) minute.Step 4: repeat step 2 - flush two (2) times for a total of three (3) flushes.Step 5: immerse devices in fresh water (sterile or distilled) for a minimum of two (2) minutes.While immersed, actuate devices and repeat steps 2 - 4 using fresh water (sterile or distilled).Step 6: air flush (step only required for 3 fr and 4 fr ureteral catheters) - use a compatible tuohy borst adapter and luer lock syringe to flush air" 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 while attempting to inject dye into cone tip catheter, the syringe was not able to connect.The doctor informed the adapter needs to be ordered.Representative advised the cone tip nor olive tip ureteral catheter are sold with an adapter.Provided plastic adapter product number (140000).

• Brand Name: BARD® WOVEN URETERAL CATHETER
• Common Device Name: URETERAL 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18400187
• Report Number: 1018233-2023-09236
• Device Sequence Number: 11452993
• Product Code: EYB
• UDI-Device Identifier: 00801741073595
• UDI-Public: (01)00801741073595
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: Health Professional
• Device Catalogue Number: 038008
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 12/27/2023
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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