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

Model Number	53816G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pain (1994); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿patient sensitivity to materials¿.The device was not returned for evaluation.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: 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."precautions: inspect the catheter before use.Do not use the product if the device or packaging is damaged.Self catheterization should follow the plan of care and advice given by your health care practitioner and be carried out only in accordance with the instructions for use provided please consult your healthcare practitioner if any conditions occur which create concern and/or difficulty during catheterization.Instructions for use: review the self catheterization procedure with a healthcare professional.1)always wash hands prior to use.2)open the catheter package by peeling the tab upwards with the aid of the finger hole.3)if desired use the adhesive label(s) to hang the package on a nearby dry vertical surface while preparing to catheterize.4)clean the opening to the urethra and the surrounding area,.Wipe from front to back to avoid fecal contamination.Wash your hands again.5)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 the insertion sleeve down the shaft, stopping at about 6"from the tip.Release the funnel.Using the insertion sleeve to hold the catheter firmly, gently pass the tip of the catheter into your urethra until the insertion sleeve nears the meatus.Repeat until urine starts to flow.6)keep the catheter steady until urine stops flowing when urine stops flowing, slowly withdraw the catheter, stopping if flow starts again until the last few drops have drained check the color odor and clarity of the urine.Any changes may need to be reported to a health care professional.".
Event or Problem Description
It was reported that the intermittent catheter was painful to use and caused bleeding and a urinary tract infection, and they did seek medical attention.This was their first time using this product.

• Brand Name: MAGIC3 GO MALE CATHETER WITH SUREGRIP
• 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 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16264305
• Report Number: 1018233-2023-00414
• Device Sequence Number: 11862768
• Product Code: EZD
• UDI-Device Identifier: 00801741136979
• UDI-Public: (01)00801741136979
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/17/2023

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 Model Number: 53816G
• Device Catalogue Number: 53816G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 01/30/2023
• 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: Required Intervention
• Patient Sex: Male