MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Magic3¿ Coude Intermittent Catheter with Sure-Grip¿ Sleeve

Catalog Number	50614
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	07/06/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient received 4 catheters that had black specks on them after he opened them up.The patient received a uti.Lot#jukx0341.No additional information provided.It was unknown what medical intervention was provided for urinary tract infection.
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.

• Brand Name: Magic3¿ Coude Intermittent Catheter with Sure-Grip¿ Sleeve
• 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 ; +1(770)784-6100
• MDR Report Key: 25820142
• Report Number: 1018233-2026-04585
• Device Sequence Number: 10734606
• Product Code: KOD
• UDI-Device Identifier: 00801741068089
• UDI-Public: (01)00801741068089(11)251115(17)301028(10)JUKX0341
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• 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): 09/08/2026

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 Catalogue Number: 50614
• Device Lot Number: JUKX0341
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/28/2026
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 07/14/2026
• Supplement Report FDA Received Date: 09/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/15/2025
• 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