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

Catalog Number	4A5144
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter phone number: (b)(6).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 patient was straight cathed in the emergency department, and the piece through which the catheter is fed into the urethra must have come off the device and was lodged in the patient's urethra.This remained there until (b)(6), when the patient called out asking when her stent was going to be removed.Due to no documentation of a stent being placed while inpatient, presented to the patient's room and saw the plastic piece lodged in the patient's urethra.They removed this manually and the patient experienced relief.After investigation into what this piece of plastic could be, it was discovered to be a piece of the specified straight cath equipment used in the ed.These items are not stocked on labor and delivery or on the mother/baby unit.They would like to know is this a known issue.They have had to remove this from other patients in the past.Is there possibly another kit they can use that has a twist lock option.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned one-photo sample noted one opened (without original packaging), used unisex touchless plus urethral catheter kit.Visual inspection of the one-photo sample noted that the introducer cap was broken from the catheter.The device history record review could not be performed without a lot number.Based on the results of the investigation, no additional actions are required at this time.Initial reporter phone number: (b)(6).Corrections made to tab(s) d and 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 patient was straight cathed in the emergency department, and the piece through which the catheter is fed into the urethra must have come off the device and was lodged in the patient's urethra.This remained there until on (b)(6), when the patient called out asking when her stent was going to be removed.Due to no documentation of a stent being placed while inpatient, presented to the patient's room and saw the plastic piece lodged in the patient's urethra.They removed this manually and the patient experienced relief.After investigation into what this piece of plastic could be, it was discovered to be a piece of the specified straight cath equipment used in the ed.These items are not stocked on labor and delivery or on the mother/baby unit.They would like to know is this a known issue.They have had to remove this from other patients in the past.Is there possibly another kit they can use that has a twist lock option.Per additional information received on 20nov2025, no medical intervention required.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: TOUCHLESS 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 ; 7707846100
• MDR Report Key: 23335166
• Report Number: 1018233-2025-09255
• Device Sequence Number: 9910102
• Product Code: FCM
• UDI-Device Identifier: 00801741030550
• UDI-Public: (01)00801741030550
• 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): 04/14/2026

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?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 4A5144
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 04/14/2026
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 04/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Other
• Patient Sex: Unknown