MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT; PVC INTERMITTENT CATHETER

Catalog Number	4A5144
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2025
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 a straight catheter kit was removed from the supply room to take into a patient¿s room, and it was noted that brown betadine fluid had leaked throughout the kit.Upon further inspection, several catheter kits were found in the supply room bin that had also leaked betadine, and some had leaked all the way through the paper part of the packaging and had dried on the outside of the packaging.The damaged kits were removed from the supply room and discarded after being shown to the unit manager and assistant manager.
Event or Problem Description
It was reported that a straight catheter kit was removed from the supply room to take into a patient¿s room, and it was noted that brown betadine fluid had leaked throughout the kit.Upon further inspection, several catheter kits were found in the supply room bin that had also leaked betadine, and some had leaked all the way through the paper part of the packaging and had dried on the outside of the packaging.The damaged kits were removed from the supply room and discarded after being shown to the unit manager and assistant manager.
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.The reported event is addressed within the labeling as it states; do not use if package is damaged.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.No additional actions can be taken at this time.Correction: d 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: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: PVC 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: 23810831
• Report Number: 1018233-2025-11192
• Device Sequence Number: 9389152
• Product Code: FCM
• UDI-Device Identifier: 00801741030550
• UDI-Public: (01)00801741030550(11)250516(17)280131(10)NGKR3314
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2026

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: 4A5144
• Device Lot Number: NGKR3314
• 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: 12/09/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 12/15/2025
• Supplement Report FDA Received Date: 02/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/16/2025
• 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