MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit; Ureteral Catheter Kit

Catalog Number	4A5142
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/21/2026
Type of Reportable Event	Serious Injury
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 by customer that the introducer for straight catheter left in patient urethra.As per customer follow up information received via email on 21may2026, no physical samples are available.There was a retained introducer in the patient¿s urethra.The introducer was successfully removed, and there was no harm to the patient.No additional care or intervention was required beyond removal.While no injury occurred, they do consider the retention event to be a high concern and are thankful that it did not result in patient harm.Additionally, this issue has occurred in several patients over approximately a six-month period, which further elevates our concern.Removal of the introducer only; no further intervention was necessary.Yes, troubleshooting attempted.Education has been reinforced with staff, and vendor rounding has been conducted to ensure proper technique and correct use of the device.In addition, we have request changes with the innovations team to ensure there was not a removable piece on this product.

• Brand Name: Bard® Touchless® Plus Unisex Pre-Lubricated Vinyl Urethral Catheter Kit
• Common Device Name: Ureteral Catheter Kit
• 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: 25392325
• Report Number: 1018233-2026-03555
• Device Sequence Number: 10719045
• Product Code: FCM
• UDI-Device Identifier: 00801741030543
• UDI-Public: (01)00801741030543(11)250509(17)280131(10)NGKR1165
• Combination Product (Y/N): Y
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2026

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: 4A5142
• Device Lot Number: NGKR1165
• Was Device Available for Evaluation?: No
• 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: 05/21/2026
• Supplement Date Received by Manufacturer: 09/15/2026
• Initial Report FDA Received Date: 06/04/2026
• Supplement Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/09/2025
• 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