MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP; COUDE CATHETER

Model Number	010112
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.
Event or Problem Description
It was reported that the coude tip was bent more than usual; therefore, the patient could not insert the catheter.
Additional Manufacturer Narrative
Received 2 unopened urological catheters.The reported event was unconfirmed since the problem could not be reproduced.Per visual inspection, the samples were examined and found the tips were not too curved.The specification for curvature is that the tips not be straight, and they were not.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." (b)(4).
Event or Problem Description
It was reported that the coude tip was bent more than usual; therefore, the patient could not insert the catheter.

• Brand Name: BARD® TIEMANN MODEL UROLOGICAL CATHETER COUDE TIP
• Common Device Name: COUDE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7038339
• Report Number: 1018233-2017-05940
• Device Sequence Number: 11238174
• Product Code: KOD
• UDI-Device Identifier: 00801741029851
• UDI-Public: (01)00801741029851
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• 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): 01/19/2018

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: 06/30/2019
• Device Model Number: 010112
• Device Catalogue Number: 010112
• Device Lot Number: NGBT0564
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 01/18/2018
• Initial Report FDA Received Date: 11/16/2017
• Supplement Report FDA Received Date: 01/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1