MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3 GO¿ INTERMITTENT URINARY CATHETER; INTERMITTENT CATHETER

Catalog Number	51812
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	12/19/2024
Type of Reportable Event	Serious Injury
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
It was reported that patient had 3 urinary tract infections in last 2 to 3 weeks because of intermittent catheters.It was unknown what medical intervention was provided for urinary tract infection.Per cardinal health information received on (b)(6) 2024, it was reported that the patient prefers to switch back to their catheter they had been using.Customer stated that the patient experienced urinary tract infection while using the intermittent catheter.
Event or Problem Description
It was reported that patient had 3 urinary tract infections in last 2 to 3 weeks because of intermittent catheters.It was unknown what medical intervention was provided for urinary tract infection.Per cardinal health information received on 22dec2024, it was reported that the patient prefers to switch back to their catheter they had been using.Customer stated that the patient experienced urinary tract infection while using the intermittent catheter.Per additional information received via mail on 06jan2025, stated that liberator had magic go 3 catheters back in stock after two and half years.The patient ordered the catheter they were using, and they tried using the magic 3 catheters and ended up with 2 bad urinary tract infections.They called the liberator and got instructions.The patient got 2 subsequent urinary tract infections in december 2024, and 2 different antibiotics were taken.
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.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: " indications for use.The magic3 go intermittent urinary catheter is intended for urological use only.It is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement.The device is passed to the urinary bladder via the urethra.Intended users.Healthcare professionals and/or lay users.Contraindications.None known.Warnings.This is a single use device.Do not resterilize 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.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 do not use device if package is opened or damaged.Inspect the catheter before use.Do not use the device if damaged.Adverse reactions.Urinary tract infection.Bleeding from the urethra.Irritation of the urethra.Instruction for use.Review the self-catheterization procedure with a healthcare professional.1.Always wash hands prior to use.2.Open the catheter package by gripping the white "v" notch and tearing downwards until insertion sleeve is fully exposed.3.Positioned comfortably with thighs spread apart, clean the opening to the urethra and the surrounding area.Wipe from front to back to avoid fecal contamination.Wash your hands again.4.Remove the catheter with the aid of the insertion handle and advance the catheter tip into the urethra.Slowly and gently insert the catheter into the urethra until urine begins to flow (approximately 1-1.5" or 2.5-3.8 cm).5.When urine stops flowing, 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.Disposal.6.Place the catheter back into the package and dispose in accordance with accepted medical practice and applicable local, state and federal laws and regulations.Do not flush down the toilet.7.Wash hands".Correction: b, d, e.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: MAGIC3 GO¿ INTERMITTENT URINARY CATHETER
• Common Device Name: INTERMITTENT 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: 21101533
• Report Number: 1018233-2024-08637
• Device Sequence Number: 21066562
• Product Code: EZD
• UDI-Device Identifier: 00801741097874
• UDI-Public: (01)00801741097874(11)241016(17)270828(10)JUJW9017
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K150345
• 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): 06/16/2025

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: 51812
• Device Lot Number: JUJW9017
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 06/16/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/16/2024
• 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; Required Intervention
• Patient Sex: Unknown