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

Catalog Number	4A5044
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Urinary Tract Infection (2120); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/15/2026
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: sections 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 customer had been using the 4a2045 kit successfully for an extended period and experienced no issues with leakage or infections.Since this product was discontinued, customers have been using the suggested replacement, sku 4a5044, which was a unisex catheter kit.Customer reports that this alternative does not work well for them, noting that it consistently leaks and does not function in the same way as the male specific design.Customer also shared that they have trialed multiple substitute products over the past few months, and all have resulted in utis and additional difficulties, making the discontinued 4a2045 the only product that reliably met their clinical needs.It was unknown what medical intervention was provided for urinary tract infection.
Event or Problem Description
It was reported that the customer had been using the 4a2045 kit successfully for an extended period and experienced no issues with leakage or infections.Since this product was discontinued, customers have been using the suggested replacement, sku 4a5044, which was a unisex catheter kit.Customer reports that this alternative does not work well for them, noting that it consistently leaks and does not function in the same way as the male specific design.Customer also shared that they have trialed multiple substitute products over the past few months, and all have resulted in utis and additional difficulties, making the discontinued 4a2045 the only product that reliably met their clinical needs.It was unknown what medical intervention was provided for urinary tract infection.
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: instructions for use: preparing for catheterization: 1.Open kit and remove contents.2.The gloves are not necessary to maintain aseptic conditions during the procedure.The gloves are for the operator's protection.Male or female catheterization: 1.Remove cap from insertion tip while squeezing tabs.Save cap for closing the bag.2.Slide the catheter halfway into the insertion tip.3.Male prepare the male urethral meatus and the surrounding area with povidone iodine swabs provided.4.Male holding the penis, advance the insertion tip into the urethra no further than the flange base.5.Place your nondominant hand on the finger control guide to stabilize catheter in urethra.With your dominant hand, grasp catheter through bag approximately 1in below the finger control guide and push catheter into urethra.The catheter should be introduced by short, repetitive pushing motions.Repeat motions until catheter reaches bladder and urine starts to flow.6.Allow urine to flow freely, making certain the catheter guide is elevated at least 4in above lower portion of the bag.Allow flow until bladder is empty or until bag is filled.Precaution: it is recommended that the collection bag be held.The catheter could possibly separate from the collection bag when urine increases weight of the bag.7.Withdraw the catheter from the urethra.Remove the remaining portion of the catheter from the collection bag by pulling it through the insertion tip.Note: the catheter is designed to pass through the insertion tip.8.The filled collection bag may be closed by replacing the cap over the insertion tip.Make sure the cap snaps on securely.Specimen collection: to collect a specimen, obtain a sample cup or tube and alcohol wipe.Remove guide tip by pulling tab(s) upward from bag.Wipe port with alcohol.Pour specimen through port at top of bag into cup or tube.Draining bag: remove insertion tip by pulling tab(s) upward from bag.Drain urine through port at top of bag.The dhr review could not be performed without a lot number.No additional actions can be taken at this time.Correction: d.Udi format updated with available product information per gudid.H11: sections 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 RUBBER URETHRAL CATHETER KIT
• Common Device Name: URETHRAL 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: 24195904
• Report Number: 1018233-2026-00406
• Device Sequence Number: 9649239
• Product Code: FCM
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• 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,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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: 4A5044
• 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: 01/15/2026
• Supplement Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 05/21/2026
• 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: Other
• Patient Sex: Male