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

Model Number	423716
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was inconclusive, as the device was not returned for evaluation.However, the potential root cause for this failure mode could be due to mechanical error (eg: pvc tube diameter exceed specification) or user related (eg: insufficient or no lubricant used during insertion).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: "to use: insert rounded end of catheter.Visually inspect the product for any imperfection or surface deteriorations prior to use.".
Event or Problem Description
It was reported that about 70 percent of the catheters were not straight.It was stated that the packaging of the catheters were bent.They had to be straightened before use.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9795156
• Report Number: 1018233-2020-01601
• Device Sequence Number: 2204414
• Product Code: KOD
• UDI-Device Identifier: 00801741038884
• UDI-Public: (01)00801741038884
• 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): 03/05/2020

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
• Operator of Device: Lay User/Patient
• Device Model Number: 423716
• Device Catalogue Number: 423716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1