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

Model Number	421714
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Patient Problem/Medical Problem (2688)
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 the patient experienced self limited bleeding and was unable to fully insert the catheters.The patient visited the emergency room where a doctor attempted to insert a catheter but was unsuccessful.The doctor explained to the patient that there was "blockage" and he could not use the catheters at that time.The patient was not alleging the catheters were the reason for the blockage, and noted that he would follow up with the urologist as suggested by er physician.The physician also noted that he may have underlying medical issues that caused the blockage.
Additional Manufacturer Narrative
The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "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".
Event or Problem Description
It was reported that the patient experienced self limited bleeding and was unable to fully insert the catheters.The patient visited the emergency room where a doctor attempted to insert a catheter but was unsuccessful.The doctor explained to the patient that there was "blockage" and he could not use the catheters at that time.The patient was not alleging the catheters were the reason for the blockage, and noted that he would follow up with the urologist as suggested by er physician.The physician also noted that he may have underlying medical issues that caused the blockage.

• Brand Name: BARD® CLEAN-CATH® INTERMITTENT CATHETER
• Common Device Name: CLEAN CATH VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8329159
• Report Number: 1018233-2019-00735
• Device Sequence Number: 14024451
• Product Code: KOD
• UDI-Device Identifier: 00801741038822
• UDI-Public: (01)00801741038822
• 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): 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 421714
• Device Catalogue Number: 421714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/21/2019
• Initial Report FDA Received Date: 02/11/2019
• Supplement Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1