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

Catalog Number	50816G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Sepsis (2067); Urinary Tract Infection (2120)
Date of Event	09/29/2025
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: sections 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 the patient is dealing with uti that led to sepsis.His concern is that it happened due to cathing and he would like to clear up issue first before placing order.No medical intervention was reported, no additional information 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.The labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Udi format updated with available product information per gudid.H11: sections 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 the patient is dealing with uti that led to sepsis.His concern is that it happened due to cathing and he would like to clear up issue first before placing order.No medical intervention was reported, no additional information provided.Spoke with customer's authorized spouse rhonda.It was reported that customer has had 4 uti's since he started using the catheters.On sep 8th the customer was sent to a rehab facility to treat his sepsis stemming from the recurrent uti's.It is unconfirmed whether the catheters caused the uti's.Lot number was unavailable at the moment but she plans to call back with lot info.
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 labeling is found to be adequate.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: b,d.Udi format updated with available product information per gudid.H11: sections 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 the patient is dealing with uti that led to sepsis.His concern is that it happened due to cathing and he would like to clear up issue first before placing order.No medical intervention was reported, no additional information provided.Spoke with customer's authorized spouse.It was reported that customer has had 4 uti's since he started using the catheters.On sep 8th the customer was sent to a rehab facility to treat his sepsis stemming from the recurrent uti's.It is unconfirmed whether the catheters caused the uti's.Lot number was unavailable at the moment but she plans to call back with lot info.

• Brand Name: MAGIC3 GO MALE COUDE CATHETER WITH SUREGRIP
• Common Device Name: MAGIC3 GO MALE
• 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: 23210897
• Report Number: 1018233-2025-08819
• Device Sequence Number: 18662256
• Product Code: EZD
• UDI-Device Identifier: 00801741137037
• UDI-Public: (01)00801741137037
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2025

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: 50816G
• 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: 09/29/2025
• Supplement Date Received by Manufacturer: 11/13/2025; 11/26/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 11/20/2025; 12/09/2025
• 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; Required Intervention
• Patient Sex: Male