MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE

Catalog Number	53616G
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that that the patient mentioned the bleeding again that he stated before.Once he put in the coude cath, he had bleeding.He didn't know it was a coude cath and had to go to the hospital to have all the blood drained out of his bladder.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.
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 that the patient mentioned the bleeding again that he stated before.Once he put in the coude cath, he had bleeding.He didn't know it was a coude cath and had to go to the hospital to have all the blood drained out of his bladder.It's unclear if lot number was requested.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 reported event is addressed within the labeling as it states, 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.If you have any clinical concerns with the use of this device for your condition, please contact your healthcare physician.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: b.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.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
• Common Device Name: INTERMITTENT 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: 23770026
• Report Number: 1018233-2025-10946
• Device Sequence Number: 21268007
• Product Code: KOD
• UDI-Device Identifier: 00801741069789
• UDI-Public: (01)00801741069789
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• 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): 12/12/2025

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: 53616G
• 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: 12/02/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 12/19/2025
• 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: Required Intervention
• Patient Sex: Male