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

Model Number	421716
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/11/2017
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.The device was not returned.
Event or Problem Description
It was reported that the surgeon was not happy with the replacement product, as the product allegedly did not drain well, especially for males.The urologist alleged that the silicone was not as smooth as the red rubber; therefore, not sliding well.One of the anaesthetists used this catheter as an intra- nasal guide for pediatric patients.
Additional Manufacturer Narrative
For the reported issue (the surgeon was not happy with replacement product as the product allegedly does not drain well especially for males.The urologist alleged that the silicone wasn't as smooth as the red rubber, therefore did not slide well.He also stated that one of the anaesthetists used this catheter as an intra- nasal guide for pediatric patients) was unconfirmed, since the catheter was found within specification.During the visual inspection no obvious defects were found in the sample.No kinks or obstructions were detected.Per functional test observed flow through the catheter.Per dimensional assessment the sample was found within specification.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.For urological use only.To use: insert rounded end of catheter.This is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of device, which may lead to device failure, and/or lead to injury, illness or death of the patient." (b)(4).
Event or Problem Description
It was reported that the surgeon was not happy with the replacement product, as the product allegedly did not drain well, especially for males.The urologist alleged that the silicone was not as smooth as the red rubber; therefore, did not slide well.One of the anaesthetists used this catheter as an intra- nasal guide for pediatric patients.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 6540710
• Report Number: 1018233-2017-02263
• Device Sequence Number: 16359946
• Product Code: KOD
• UDI-Device Identifier: 00801741038839
• UDI-Public: (01)00801741038839(10)NGAW2118
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K802665
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2017

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: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 421716
• Device Catalogue Number: 421716
• Device Lot Number: NGAW2118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2017
• Initial Date Received by Manufacturer: 04/13/2017
• Supplement Date Received by Manufacturer: 09/12/2017
• Initial Report FDA Received Date: 05/03/2017
• Supplement Report FDA Received Date: 09/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1