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

Model Number	4A6142
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
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 intermittent catheter hose was leaking.
Event or Problem Description
It was reported that the intermittent catheter hose was leaking.
Additional Manufacturer Narrative
Bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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 PLUS UNISEX PRE-LUBRICATED VINYL URETHRAL CATHETER
• Common Device Name: PRE-LUBRICATED VINYL URETHRAL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10752017
• Report Number: 1018233-2020-20533
• Device Sequence Number: 19793450
• Product Code: FCM
• UDI-Device Identifier: 00801741030598
• UDI-Public: (01)00801741030598
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K910653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 4A6142
• Device Catalogue Number: 4A6142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 10/28/2020
• Supplement Report FDA Received Date: 02/01/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other