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

Catalog Number	51814
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Malfunction
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 said when removing it felt like it was scraping her insides.The edges were very rough.It is unclear if troubleshooting was performed or lot number requested.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 reported event is addressed within the labeling as it state: 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.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.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.A dhr could not be performed since no lot number was provided.No additional actions can be taken at this time.Correction: 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 said when removing it felt like it was scraping her insides.The edges were very rough.It is unclear if troubleshooting was performed or lot number requested.No medical intervention was reported.No additional information provided.

• 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 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: 23832693
• Report Number: 1018233-2025-11299
• Device Sequence Number: 17416560
• Product Code: EZD
• UDI-Device Identifier: 00801741097898
• UDI-Public: (01)00801741097898
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 51814
• 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: 12/12/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/13/2026
• 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: Female