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

Model Number	423716
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned for evaluation.The potential root cause for this failure mode could be user related (eg: excessive use of lubricant on the catheter) or mechanical error (eg: excessive cyclohexanone causing blocked lumen).The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: for urological use only.To use: insert rounded end of catheter.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.Visually inspect the product for any imperfections or surface deterioration prior to use.The device was not returned.
Event or Problem Description
It was reported that the coude intermittent catheter became clogged with surgical silicone that the patient was using as a lubricant.The patient was unable to void.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: COUDE INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8802296
• Report Number: 1018233-2019-04008
• Device Sequence Number: 326922
• 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: distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 423716
• Device Catalogue Number: 423716
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1