MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER; TOUCHLESS MALE CATHETER

Model Number	4A3053
Medical Device Problem Code	Gel Leak (1267)
Health Effect - Clinical Codes	No Patient Involvement (2645); 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.
Event or Problem Description
It was reported that the iodine "busted" in the kit.
Additional Manufacturer Narrative
The reported event was confirmed.Visual evaluation of the returned sample noted one touchless male urethral catheter kit with an opened original packaging.The iodine was noted to have penetrated the packaging and the contents within.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿bard touchless urethral catheter kit - caution: this product contains natural rubber latex which may cause allergic reactions.Preparing for procedure: - open kit and remove contents.-remove top of calibrated plastic bag as directed and open tube of lubricant.-by squeezing rigid collar, open neck of bag to form round shape.-empty tube of lubricant into top chamber of bag so that lubricant is deposited at bottom of chamber.(caution: care should be taken not to contaminate edges or inside of the bag with fingers or tube).-open package of povidone-iodine swabs as directed.-prep urethral meatus and the area surrounding the meatus with swabs.-while squeezing rigid collar bring top chamber of bag over head of penis.-meatus should be press tight against rigid catheter guide.To feed catheter into urethra -if user is predominately left-handed reverse hands suggested below -stabilize penis with top chamber of bag between index and second finger of left hand.Place thumb and ring finger on opposite sides of rigid catheter guide recess to stabilize catheter.-with right hand grasp catheter through bag approximately 1¿ below rigid catheter guide and push catheter toward meatus.-stabilize catheter with thumb and ring finger and return right hand to position approximately 1¿ away.-repeat motions until catheter reaches bladder and urine starts to flow.(if some resistance is felt while moving catheter through urethra, change position of urethra with slight up or down movement of left hand while holding penis firmly within top chamber.)¿.
Event or Problem Description
It was reported that the iodine "busted" in the kit.

• Brand Name: BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Common Device Name: TOUCHLESS MALE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8350608
• Report Number: 1018233-2019-00867
• Device Sequence Number: 206516
• Product Code: FCM
• UDI-Device Identifier: 00801741030680
• UDI-Public: (01)00801741030680
• 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: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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 Expiration Date: 01/31/2021
• Device Model Number: 4A3053
• Device Catalogue Number: 4A3053
• Device Lot Number: NGCW3123
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Initial Date Received by Manufacturer: 01/28/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 02/19/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1