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

Catalog Number	4A6144
Medical Device Problem Code	Improper Chemical Reaction (2952)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2025
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.The reported product number is unknown.The udi number for this product is not available.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 customer had been using these intermittent catheters for years.They used to have too much gel, but now there was too little.Customer was not sure what happened, but sometimes catheters were hard to insert all the way in.
Event or Problem Description
It was reported that customer had been using these intermittent catheters for years.They used to have too much gel, but now there was too little.Customer was not sure what happened, but sometimes catheters were hard to insert all the way in.Per additional information received via email on 25apr2025, it was reported that there was not enough gel lubricant in the closed catheter.The device was not replaced.There was no medical intervention required.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: a, d, g, 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.
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.No actions can be taken at this time since a root cause was not identified.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.A labeling review is not required because labeling could not have prevented the reported issue.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.
Event or Problem Description
It was reported that customer had been using these intermittent catheters for years.They used to have too much gel, but now there was too little.Customer was not sure what happened, but sometimes catheters were hard to insert all the way in.Per additional information received via email on 25apr2025, it was reported that there was not enough gel lubricant in the closed catheter.The device was not replaced.There was no medical intervention required.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER
• 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 30014 ; 7707846100
• MDR Report Key: 21721834
• Report Number: 1018233-2025-02108
• Device Sequence Number: 9437576
• Product Code: FCM
• UDI-Device Identifier: 00801741030604
• UDI-Public: (01)00801741030604(11)241009(17)290831(10)NGJW0446
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/12/2025

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: 4A6144
• Device Lot Number: NGJW0446
• 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: 03/11/2025
• Supplement Date Received by Manufacturer: 04/25/2025; 05/12/2025
• Initial Report FDA Received Date: 03/28/2025
• Supplement Report FDA Received Date: 04/29/2025; 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2024
• 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 Age: 50 YR
• Patient Sex: Male
• Patient Weight: 64 KG