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

Model Number	53812G
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	08/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the customer had used hydrophilic male magic 3 go catheter and got a urinary tract infection.Customer preferred to use the female catheter due to this one contracting a urinary tract infection.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr was reported in error as it was found to be a cascading failure of an event previously reported.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 customer had used hydrophilic male magic 3 go catheter and got a urinary tract infection.Customer preferred to use the female catheter due to this one contracting a urinary tract infection.

• Brand Name: MAGIC3 GO MALE CATHETER WITH SUREGRIP
• Common Device Name: MAGIC3 GO MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15292539
• Report Number: 1018233-2022-06646
• Device Sequence Number: 15280792
• Product Code: EZD
• UDI-Device Identifier: 00801741136955
• UDI-Public: (01)00801741136955
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/26/2022

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 Model Number: 53812G
• Device Catalogue Number: 53812G
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/15/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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