MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BD READY-TO-USE HYDROPHILIC CATHETER; INTERMITTENT CATHETER

Catalog Number	RTU14F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that patient said she got 2 uti's from the start of cathing.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.It was unknown what medical intervention was provided for urinary tract infection.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.All available udi information is being provided.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 patient said she got 2 uti's from the start of cathing.It's unclear if lot number was requested.No additional information provided.It was unknown what medical intervention was provided for urinary tract infection.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.The reported event is addressed within the labeling as it state: instructions for intermittent catheters: always wash hands prior to use.Open the catheter package by peeling the tab downwards with the aid of the finger hole or the ends of the package.If desired, hang the package by removing the blue adhesive sticker and attach it to a nearby dry vertical surface while preparing to catheterize.For males: get yourself into a comfortable position.Clean the opening of the urethra¿and the surrounding area using an alcohol-free wet wipe or soap and water.Wash your hands again.Hold the insertion sleeve with your dominant hand and squeeze it to grip the catheter shaft as you remove the catheter from the pack.Next, hold the catheter funnel above the insertion sleeve with your other hand and slide down the shaft, stopping at about six inches from the tip.Release the funnel.Using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter firmly into your urethra until the insertion sleeve nears the meatus.Repeat until urine starts to flow.Note: if you are using a coude tip catheter, the raised notch on the catheter funnel will indicate the orientation in which the tip curves upward.Ensure that the coude indicator notch is facing upwards during insertion.For females: get yourself into a comfortable position and wash around the urethral opening, spreading the labia and wiping from front to back using an alcohol-free wet wipe or soap and water.(wiping from back to front can spread bacteria from the perineum and should be avoided.) wash your hands again and remove the catheter from the pouch, holding the funnel end.Spread apart the labia with the non-dominant hand.With the dominant hand, insert the catheter tip into the urethral opening, allowing it to pass gently up into the bladder until urine begins to flow.Advance the catheter about another inch.When urine stops flowing, slowly begin to withdraw the catheter.It is recommended to slowly rotate the catheter during withdrawal, stopping each time urine begins to flow.Check the color, odor and clarity of the urine.Any changes may need to be reported to a health care professional.Finish by disposing of the catheter and its packaging.Wash your hands with soap and water, just as you would normally do after using the toilet.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.All available udi information is being provided.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.

• Brand Name: BD READY-TO-USE HYDROPHILIC CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 23764878
• Report Number: 1018233-2025-10910
• Device Sequence Number: 16100605
• Product Code: GBM
• UDI-Device Identifier: 06948796204063
• UDI-Public: (01)06948796204063
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K192468
• 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): 12/12/2025

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 Catalogue Number: RTU14F
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/09/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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: Female