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

Catalog Number	50816G
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Skin Inflammation/ Irritation (4545)
Date of Event	06/03/2025
Type of Reportable Event	Malfunction
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.No actions can be taken at this time since a root cause was not identified.A dhr could not be performed since no lot number was provided.A labeling review was not performed because labeling could not have prevented the reported failure.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 patient said the tip of the intermittent catheter was not made properly and it was too sharp and caused them a lot of irritation.It was unclear if lot number was requested.No additional information provided.No medical intervention was reported.
Event or Problem Description
Patient said the tip of the catheter is not made properly and it is too sharp and caused him a lot of irritation.It is unclear if lot number was requested.No additional information provided.No medical intervention was reported.Per customer via phone on 01aug2025, it was reported that they were forced to switched to magic 3 catheters, tip was sharp and feels like urethra was being cut inside, lubricant was like oil and their hand slipped because of the oiliness.They were no longer using but wishes to send a sample in and would like a results letter.
Additional Manufacturer Narrative
The reported event is unconfirmed- product met specifications.Visual: received 5 unopened magic3 go.Verified material number 50816g and batch number jujx0486.Visual inspection noted no obvious observations.No nicks, burrs, bends, flash, bumps or sharps present.Therefore, the product meets specifications.As the reported event is unconfirmed, a risk and labeling review is not required.A review of the device history record was not necessary due to the reported event being unconfirmed.Corrections: d, e, h.All available udi information is being provided.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: 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: 22298651
• Report Number: 1018233-2025-04803
• Device Sequence Number: 9311686
• Product Code: EZD
• UDI-Device Identifier: 00801741137037
• UDI-Public: (01)00801741137037(11)241112(17)260928(10)JUJX0486
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 11/04/2025

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 Expiration Date: 09/28/2026
• Device Catalogue Number: 50816G
• Device Lot Number: JUJX0486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 11/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2024
• 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