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

Model Number	423714
Health Effect - Clinical Codes	Discomfort (2330); 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 device was not returned.
Event or Problem Description
It was reported that some of the catheters were not going all the way in.The patient stated that it felt like there was an obstruction.Additionally, some of the catheters were twisted and crinkled upon delivery, straight out of the box.The patient's wife advised via phone on (b)(6) 2019, that they received the replacement catheters from a different lot and they were working much better.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿visually inspect the product for any imperfections or surface deterioration prior to use.To use: insert rounded end of catheter.".
Event or Problem Description
It was reported that some of the catheters were not going all the way in.The patient stated that it felt like there was an obstruction.Additionally, some of the catheters were twisted and crinkled upon delivery, straight out of the box.The patient's wife advised via phone on (b)(6)2019, that they received the replacement catheters from a different lot and they were working much better.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8386969
• Report Number: 1018233-2019-01135
• Device Sequence Number: 2926044
• Product Code: KOD
• UDI-Device Identifier: 00801741038877
• UDI-Public: (01)00801741038877
• 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,Followup
• Report Date (Section B): 03/21/2019

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 Expiration Date: 02/28/2018
• Device Model Number: 423714
• Device Catalogue Number: 423714
• Device Lot Number: NGCV2015
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 03/05/2019
• Initial Report FDA Received Date: 03/04/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1