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

Model Number	420714
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Date of Event	11/12/2020
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.The device was not returned.
Event or Problem Description
It was reported that the patient ran out of supplies and reused same catheter multiple times.This resulted in urinary tract infection.Sample order (hmo) was created.It was unknown what medical intervention was provided for urinary tract infection.
Event or Problem Description
It was reported that the patient ran out of supplies and reused the same catheter multiple times which resulted in a urinary tract infection.It is unknown what medical intervention was provided for the urinary tract infection.
Additional Manufacturer Narrative
The reported event was confirmed as a use related.The root cause of this failure mode was the device performance was compromised due to the reuse.The device had failed to meet the specifications due to the user.The product used for the treatment purposes.The failure was caused by the misuse of the product.The device was not returned for evaluation.The lot number was 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.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." correction: e, h 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: CLEAN CATH VINYL CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10960674
• Report Number: 1018233-2020-21472
• Device Sequence Number: 10902254
• 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): 02/24/2021

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?: No
• Operator of Device: Lay User/Patient
• Device Model Number: 420714
• Device Catalogue Number: 420714
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/12/2020
• Supplement Date Received by Manufacturer: 02/24/2021
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 03/22/2021
• 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