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

Model Number	4A3053
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 7 bard touchless catheters did not have jelly or iodine.
Event or Problem Description
It was reported that 7 bard touchless catheters did not have jelly or iodine.
Additional Manufacturer Narrative
The reported event was inconclusive due to poor sample condition.Visual evaluation of the returned photo sample noted seven opened (in original packaging), unused touchless catheter kits.There were 4 unique lot numbers (ngbn1454, ngbp2308, ngdq0565 and ngdr2712) for 6 of the samples and one unknown lot number due to the lot being out of frame.One sample kit to have iodine stains, but it was unclear whether this came from an iodine packet within that kit or some external source.As only the outer packaging label was shown and none of the components within could be observed, it could not be visually determined which are missing jelly or iodine packets.A potential root cause for this reported failure could be incorrect operation.The lot number for the device associated with this particular event could not be identified by the complainant; however, the following lot numbers (lot no: ngbn1454, expiry date: 31may2019, manufacturing date: 16feb2017 ; lot no: ngbp2308 ,expiry date: 30jun2019, date of manufacture: 04mar2017 ; lot no: ngdq0565 ,expiry date: 30nov2021, date of manufacture: 11apr2019 ; lot no: ngdr2712 ,expiry date: 31dec2021, date of manufacture: 26may2019.) were in use at the time this event occurred.These lot numbers underwent a manufacturing review and the device history records found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "instructions for use 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 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 pressed 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 through catheter guide recess 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.)" h11:section a through f - the information provided by bd 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 bd.

• Brand Name: BARD TOUCHLESS URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Common Device Name: TOUCHLESS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10431836
• Report Number: 1018233-2020-05301
• Device Sequence Number: 14446805
• 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): 12/23/2020

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: 4A3053
• Device Catalogue Number: 4A3053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 08/20/2020
• Supplement Report FDA Received Date: 12/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1