MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CLEAN-CATH® INTERMITTENT CATHETER; CLEAN CATH VINYL CATHETER

Model Number	421716
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event is inconclusive since the device was not returned for evaluation.A potential root cause identified was "incorrectly sharpened dies".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: "visually inspect the product for any imperfections or surface deterioration prior to use.".
Event or Problem Description
It was reported that the eyelets were too small and not "polished" causing bleeding.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: CLEAN CATH VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8941878
• Report Number: 1018233-2019-05189
• Device Sequence Number: 2610228
• Product Code: KOD
• UDI-Device Identifier: 00801741038839
• UDI-Public: (01)00801741038839
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2019

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
• Operator of Device: Lay User/Patient
• Device Model Number: 421716
• Device Catalogue Number: 421716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1