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

Catalog Number	RTU14F
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	02/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the pt stated she had some bleeding, she saw her doctor today and he wants her to only cath.1 per day.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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
Pt stated she had some bleeding, she saw her doctor today and he wants her to only cath 1 per day.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.
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.Warnings: this is a sterile, single use device.Do not re-sterilize any portion of this device.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 device failure, and/or lead to injury, illness or death of the patient.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Precautions: 1.Federal (usa) law restricts this device to sale by or on the order of a physician.2.Prior to use of this device, be sure to read the complete information on how to use this device including warnings, precautions and instructions for use, and all other package inserts and labels supplied with the product and accessories.3.Inspect the catheter before use.If the inner packaging is open or broken, do not use the catheter, and do not try to re-sterilize it.4.Do not use the catheter if there is no water inside the inner packaging or if the product is past its expiry date.5.Self-catheterization should only be carried out under medical advice and only in accordance with instructions provided.You should always follow the plan of care and advice given by your healthcare professional.6.Please consult your doctor before using this product if any of the following conditions are present: fever, chills, back pain, discomfort on emptying the bladder, severed urethra, unexplained urethral bleeding, pronounced stricture, false passage, urethritis - inflammation of the urethra, prostatitis - inflammation of the prostate gland, epididymitis - inflammation of the epididymis (testicle tube).7.The catheter is for intermittent use only.8.The indwelling time of the bd® ready-to-use hydrophilic catheter is about 1-3 minutes.When urine drainage is complete, slowly withdraw catheter from urethra.A risk review was not performed due to the applicable fmea's were controlled by the bever supplier.The dhr review could not be performed without a lot number.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.

• Brand Name: BD READY-TO-USE HYDROPHILIC CATHETER
• Common Device Name: INTERMITTENT HYDROPHILIC 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: 24373248
• Report Number: 1018233-2026-00884
• Device Sequence Number: 12158443
• Product Code: GBM
• UDI-Device Identifier: 06948796204063
• UDI-Public: (01)06948796204063
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 03/20/2026

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: 02/03/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/24/2026
• 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