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

Catalog Number BUC14F

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/23/2023

Event Type  Injury  

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential failure mode could be "biocompatibility issues " and therefore a potential root cause for this failure could be "unsuitable material'.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: "instructions for use for bd intermittent catheters: description: the bd intermittent catheter is a single use, disposable clear polyvinyl chloride (pvc) catheter.Indications for use: bd intermittent catheters are indicated for intermittent catheterization of the urethra for those individuals who are unable to promote a natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.The catheter is inserted into the urethra to reach the bladder allowing urine to drain.Contraindications the product is forbidden for use if the patient has acute urethritis, acute prostatitis, acute epididymitis, and/or acute urinary tract bleeding or injury.Warnings to help reduce the potential risk of infection and/or other complications, do not re-use.Dispose of appropriately after procedure.If discomfort or any sign of trauma occurs, discontinue use immediately and consult your doctor.Precautions: 1.Federal (usa) law restricts this device to sale by or on the order of a physician.2.Urethral catheter for urological use only.3.Sterile if package is unopened or undamaged.4.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.5.Do not use the catheter if the product is past its expiry date.6.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.Generally, for urethral intermittent self-catheterization (isc), it is typical to catheterize at least 4 times a day between 4-6 hour intervals.If you are unsure about your catheterization, please contact your regular healthcare professional.7.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.8.Please consult your doctor before using this product if any of the following conditions are present: 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).9.The indwelling time of the bd intermittent catheter is about 1-3 minutes.When urine drainage is complete, slowly withdraw catheter from urethra.10.The catheter is for single use only and must then be discarded.Note: store boxes in a cool and dry place.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.If desired, apply water-soluble lubricant to catheter.4.Gently insert rounded end of catheter into urethra until urine begins to flow.5.When urine stops flowing, remove catheter from urethra.6.Dispose of catheter in accordance with local rules and regulations.7.Wash your hands.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." 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.H3 other text : the device was not returned.

Event Description

It was reported that patient got a urinary tract infection (uti).Patient had some bleeding, but they have seen their doctor, and they prescribed them antibiotics or medication.The bleeding stopped after patient started taking the medication.Patient said they did not experience any pain using the products.

• Brand Name: INTERMITTENT CATHETER
• Type of Device: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 18147777
• MDR Text Key: 328265037
• Report Number: 1018233-2023-08156
• Device Sequence Number: 1
• Product Code: GBM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111405
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: BUC14F
• Device Lot Number: A14601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/23/2023
• Event Location: Other
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention