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

Model Number 4A5142

Device Problem Scratched Material (3020)

Patient Problem Hemorrhage/Bleeding (1888)

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 touchless plus catheter was sharp and kept cutting the patient during insertion, which caused the patient to bleed.No medical intervention was reported.

• 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: 9608330
• MDR Text Key: 180399818
• Report Number: 1018233-2020-00447
• Device Sequence Number: 1
• Product Code: FCM
• UDI-Device Identifier: 00801741030543
• UDI-Public: (01)00801741030543
• 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: Other,Consumer,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/20/2020

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 Model Number: 4A5142
• Device Catalogue Number: 4A5142
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/30/2019
• Initial Date FDA Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Female