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

Catalog Number	50816G
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/28/2025
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: 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 reportesd that the patient said the curved tip is causing blood in his urine.Per additional information received via phone on (b)(6) 2025 and it was reported that he visited the doctor and was diagnosed with a uti.Customer did not specify what type of medicine was provided to treat the uti.Customer stated that the curved catheters were causing him to bleed and he spoke with his doctor several times about submitting a new prescription for a different type of catheter.Customer also spoke with liberator and was advised that they have to receive the new prescription directly from the doctor before any changes can be made.Customer was very upset and disconnected the call.
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.Instructions for use were reviewed for this investigation.The labeling is found to be adequate.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.
Event or Problem Description
Pt said the curved tip is causing blood in his urine.Per additional information received via phone on 28jul2025 and it was reported that he visited the doctor and was diagnosed with a uti.Customer did not specify what type of medicine was provided to treat the uti.Customer stated that the curved catheters were causing him to bleed and he spoke with his doctor several times about submitting a new prescription for a different type of catheter.Customer also spoke with liberator and was advised that they have to receive the new prescription directly from the doctor before any changes can be made.Customer was very upset and disconnected the call.
Event or Problem Description
Pt said the curved tip is causing blood in his urine.Per additional information received via phone on 28jul2025 and it was reported that he visited the doctor and was diagnosed with a uti.Customer did not specify what type of medicine was provided to treat the uti.Customer stated that the curved catheters were causing him to bleed and he spoke with his doctor several times about submitting a new prescription for a different type of catheter.Customer also spoke with liberator and was advised that they have to receive the new prescription directly from the doctor before any changes can be made.Customer was very upset and disconnected the call.
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.Instructions for use were reviewed for this investigation and were found to be adequate.The reported event is addressed within the labeling.The dhr review could not be performed without a lot number.Correction - f, h.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 MALE COUDE CATHETER WITH SUREGRIP
• Common Device Name: COUDE 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: 22644673
• Report Number: 1018233-2025-06252
• Device Sequence Number: 8609426
• Product Code: EZD
• UDI-Device Identifier: 00801741137037
• UDI-Public: (01)00801741137037
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 10/28/2025

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: 07/28/2025
• Supplement Date Received by Manufacturer: 10/03/2025; 10/28/2025
• Initial Report FDA Received Date: 07/29/2025
• Supplement Report FDA Received Date: 10/09/2025; 10/29/2025
• 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
• Patient Sex: Male