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

Model Number 4A2044

Device Problems Fluid/Blood Leak (1250); Misassembled (1398); Material Integrity Problem (2978)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the plastic piece at the end of the touchless catheter was not properly sealed together and caused it to leak.

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: "contains or presence of natural rubber latex.Caution: this product contains natural rubber latex which may cause allergic reactions.Single use: do not resterilize: warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.".

Event Description

It was reported that the plastic piece at the end of the touchless catheter was not properly sealed together and caused it to leak.

• Brand Name: BARD® TOUCHLESS® URETHRAL CATHETER KIT WITH RED RUBBER CATHETER
• Type of Device: TOUCHLESS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8227135
• MDR Text Key: 132501000
• Report Number: 1018233-2019-00147
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 00801741030642
• UDI-Public: (01)00801741030642
• Combination Product (y/n): N
• PMA/PMN Number: K910653
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 02/01/2019

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
• Device Operator: Lay User/Patient
• Device Model Number: 4A2044
• Device Catalogue Number: 4A2044
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/19/2018
• Initial Date FDA Received: 01/08/2019
• Supplement Dates Manufacturer Received: 01/12/2019
• Supplement Dates FDA Received: 02/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1