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	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2025
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 lubricant on the intermittent catheter was very greasy and thick not thin.Direct consumer and had samples to return.
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.A labeling review is not required because labeling could not have prevented the reported issue.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections: b, d, 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.
Event or Problem Description
It was reported that the lubricant on the intermittent catheter was very greasy and thick not thin.Direct consumer and had samples to return.Per customer via phone on 24may2025, it was reported that the catheters that the customer received had greasy and thick lubricant on them.Lot number recorded, but the customer threw the catheters aways no sample available.Customer now using a different type that works better for them.

• 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 30014 ; 7707846100
• MDR Report Key: 22166803
• Report Number: 1018233-2025-04260
• Device Sequence Number: 18443856
• Product Code: EZD
• UDI-Device Identifier: 00801741137037
• UDI-Public: (01)00801741137037(11)241112(17)270928(10)JUJX0486
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 50816G
• Device Lot Number: JUJX0486
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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