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

Model Number	4A5108
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 information provided by bard represents all of 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 bard.The device was not returned.
Event or Problem Description
It was reported that the drain bag tubing became kinked.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use state the following: "instructions for use: preparing for catheterization: open kit and remove contents.The gloves are not necessary to maintain aseptic conditions during the procedure.The gloves are for the operator's protection.Male/female catheterization: remove cap from insertion tip while squeezing tabs.Save cap for closing the bag.Slide the catheter halfway into the insertion tip.Male - prepare the male urethral meatus and the surrounding area with povidone-iodine swabs provided.Female - prepare the female urethral meatus by holding the outer labia apart and prep the urethral meatus and surrounding area with povidone iodine swabs provided.Male - holding the penis, advance the insertion tip into the urethra no further than the flange base.Female - spread the inner labia, advance the insertion tip into the urethra no further than the flange base.Release the inner labia.Place your nondominant hand on the finger control guide to stabilize catheter in urethra.With your dominant hand, grasp catheter through bag approximately 1" 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.Allow urine to flow freely, making certain the catheter guide is elevated at least 4" 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.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.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/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/tube." (b)(4).
Event or Problem Description
It was reported that the catheter cap caused the catheter to kink, making the catheter unusable.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: TOUCHLESS PLUS INTERMITTENT CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6855117
• Report Number: 1018233-2017-04720
• Device Sequence Number: 712386
• Product Code: FCM
• UDI-Device Identifier: 00801741030567
• UDI-Public: (01)00801741030567
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/17/2017

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 Model Number: 4A5108
• Device Catalogue Number: 4A5108
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 11/16/2017
• Initial Report FDA Received Date: 09/11/2017
• Supplement Report FDA Received Date: 11/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1