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

Model Number	420714
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	09/14/2020
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 patient had urinary tract infection and patient felt that it might be because of the catheters.Also stated patient had issues with the insertion.Medical intervention was unknown.
Event or Problem Description
It was reported that the patient had urinary tract infection and felt that it might be because of the catheters.Also, stated the patient had issues with the insertion.Per follow up, the customer noted that the infection was treated with prescribed antibiotics and the catheters were difficult to insert, but the patient was still able to use them.
Additional Manufacturer Narrative
The reported event was inconclusive, as no sample returned for evaluation.A potential root cause for this failure mode could be due to "outside diameter was too large/ rough or irregular shape protrusions." the device used for the treatment, though it was unknown whether the device related to the reported event or met specifications.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.For urological use only.To use: insert rounded end of catheter.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.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.Caution: federal (usa) law restricts this device to sale by or on the order of a physician." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

• Brand Name: BARD CLEAN-CATH INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10667195
• Report Number: 1018233-2020-20088
• Device Sequence Number: 11650690
• Product Code: KOD
• UDI-Device Identifier: 00801741038747
• UDI-Public: (01)00801741038747
• 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,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2021

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/30/2024
• Device Model Number: 420714
• Device Catalogue Number: 420714-BARD
• Device Lot Number: NGDY1117
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/14/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/12/2020
• Supplement Report FDA Received Date: 02/05/2021
• 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; Required Intervention