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

Model Number	4A5110
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); 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, after insertion of the catheter into the patient, the catheter kinked when the patient was repositioned to try to avoid the catheter leakage issue.No medical intervention was required.
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 were found adequate and state the following: ¿bard® touchless¿ plus unisex pre-lubricated urethral catheter kit contents: vinyl urethral catheter 1100cc collection bag 3 povidone-iodine swabs 2 ambidextrous gloves waterproof underpad units unités unidades sterilized using ethylene oxide caution: federal (usa) law restricts this device to sale by or on the order of a physician.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and with applicable local, state and federal laws and regulations.Single use do not resterilize.Manufactured in mexico.Bard and touchless are trademarks and/or registered trademarks of c.R.Bard, inc.C.R.Bard, inc.Covington, ga 30014 usa 1-800-526-4455 www.Bardmedical.Com pk7635295 02/2013 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/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.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.4.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.5.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.6.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.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/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.Draining bag: remove insertion tip by pulling tab(s) upward from bag.Drain urine through port at top of bag.Cap insertion tip tabs control guide 1100cc collection bag.".
Event or Problem Description
It was reported that the catheter kinked when the patient moved in certain positions, therefore there was a backflow of urine into the patient.No medical intervention was required.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Common Device Name: TOUCHLESS UNISEX CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7894816
• Report Number: 1018233-2018-04313
• Device Sequence Number: 16570712
• Product Code: FCM
• UDI-Device Identifier: 00801741030574
• UDI-Public: (01)00801741030574
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2018

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: Health Professional
• Device Model Number: 4A5110
• Device Catalogue Number: 4A5110
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/29/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/20/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1