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

Model Number 4A5144

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported event could not be confirmed, and it was unknown whether the device had met specifications due to no sample being returned for evaluation.The product was used for treatment purposes, and a potential failure mode could be ¿missing components /accessories¿ with a potential root cause of ¿incorrect operation¿.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: "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.".

Event Description

It was reported that 6 of the catheter kits did not have catheters inside.

• Brand Name: BARD® TOUCHLESS® PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER KIT
• Type of Device: TOUCHLESS PLUS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9602444
• MDR Text Key: 175433682
• Report Number: 1018233-2020-00403
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 00801741030550
• UDI-Public: (01)00801741030550
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K910653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/17/2020

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2022
• Device Model Number: 4A5144
• Device Catalogue Number: 4A5144
• Device Lot Number: NGDS3506
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/26/2019
• Initial Date FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1