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

Model Number	421614
Medical Device Problem Codes	Misassembled (1398); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
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 product was packaged incorrectly and allegedly caused the patient a urinary tract infection.
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 product was packaged incorrectly and allegedly caused the patient a urinary tract infection.
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 product was packaged incorrectly and allegedly caused the patient a urinary tract infection.

• Brand Name: BARD® CLEAN-CATH® CATHETER
• Common Device Name: VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8339559
• Report Number: 1018233-2019-00786
• Device Sequence Number: 206255
• Product Code: KOD
• UDI-Device Identifier: 00801741038976
• UDI-Public: (01)00801741038976
• 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,Followup
• Report Date (Section B): 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 421614
• Device Catalogue Number: 421614
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/24/2019
• Supplement Date Received by Manufacturer: 02/21/2019; 05/03/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/14/2019; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other