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

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 the red rubber catheters in the kits were smaller and some were bigger.
Event or Problem Description
It was reported that the red rubber catheters in the kits were smaller and some were bigger.Per follow up on 23jul2020, the customer noted that some of the catheters in the kit were smaller than 14fr.The catheter was more flexible when smaller and resulted in bending during insertion.
Additional Manufacturer Narrative
The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to "incorrect line clearance / mixture in incoming inspection".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: "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.Open package of povidone-iodine swabs as directed.Prep urethral meatus and the area surrounding 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.Cautions: after use this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations." 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.H3 other text : the device was not returned.

• Brand Name: BARD TOUCHLESS URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Common Device Name: TOUCHLESS CATHETER KIT
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10309244
• Report Number: 1018233-2020-04713
• Device Sequence Number: 14317292
• 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): 10/05/2020

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: Other
• Device Expiration Date: 08/31/2021
• Device Model Number: 4A3053
• Device Catalogue Number: 4A3053
• Device Lot Number: NGCY2693
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/01/2020
• Supplement Date Received by Manufacturer: 09/13/2020
• Initial Report FDA Received Date: 07/22/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1