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

Catalog Number	53814G
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2025
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: 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 reported that the pt said that it looks like the machine crimps the side of package and cuts a hole in it and not sterile and set them aside and throws away because not sterile - the ones he got originally were in a green package he liked the package better.We spoke about the catheters and the ones he used to get in the green package he liked the package better because it would hang/attach to the wall or door and he said they were the magic go.I told him they did redesign the catheters so maybe it is a change in packaging - let pt know if he has any more trouble with messed up or opened catheters to please cb and we would replace them and need to get the lot# off the package.It's unclear if lot number was requested.Unclear if medical intervention was provided.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: precautions: do not use device if package is opened or damaged.Inspect the catheter before use.Do not use the device if damaged.The dhr review could not be performed without a lot number.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 said that it looks like the machine crimps the side of package and cuts a hole in it and not sterile and set them aside and throws away because not sterile.The ones he got originally were in a green package he liked the package better.We spoke about the catheters and the ones he used to get in the green package he liked the package better because it would hang/attach to the wall or door and he said they were the magic go.I told him they did redesign the catheters so maybe it is a change in packaging.Let pt know if he has any more trouble with messed up or opened catheters to please cb and we would replace them and need to get the lot# off the package.It's unclear if lot number was requested.Unclear if medical intervention was provided.No additional information provided.

• Brand Name: MAGIC3 GO MALE CATHETER WITH SUREGRIP
• Common Device Name: MAGIC3 GO
• 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: 23771533
• Report Number: 1018233-2025-10982
• Device Sequence Number: 15869884
• Product Code: EZD
• UDI-Device Identifier: 00801741136962
• UDI-Public: (01)00801741136962
• 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
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 53814G
• 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: Other
• Patient Sex: Unknown