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

Model Number	423714
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that the tip of the device was misaligned with the dot indicator used for insertion; as a result, the device could not be inserted.
Event or Problem Description
It was reported that the tip of the device was misaligned with the dot indicator used for insertion; as a result, the device could not be inserted.
Additional Manufacturer Narrative
The reported event was unconfirmed.Received a sample (coude intermittent catheter) in original packaging and observed packaging have been opened.Visually inspection performed on returned sample.The position of tip was aligned with the dot catheter.This observation is unconfirmed and not as per reported event.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "visually inspect the product for any imperfections or surface deterioration prior to use.To use: insert rounded end of catheter." (b)(4).

• 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; lot 57c; covington GA 30014
• MDR Report Key: 6704817
• Report Number: 1018233-2017-03643
• Device Sequence Number: 11009312
• Product Code: KOD
• UDI-Device Identifier: 00801741038877
• UDI-Public: (01)00801741038877
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 02/23/2018

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 Expiration Date: 07/31/2020
• Device Model Number: 423714
• Device Catalogue Number: 423714
• Device Lot Number: NGAV5074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2017
• Initial Date Received by Manufacturer: 06/19/2017
• Supplement Date Received by Manufacturer: 02/22/2018
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1