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

Model Number	421614
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause for this failure mode could be ¿patient sensitivity to materials¿.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the clean cath vinyl catheter ifus are found to be adequate based on past reviews.
Event or Problem Description
It was reported that the customer experiences frequent utis with use of this catheter.The customer would prefer the catheter to be able to be opened from either end.
Additional Manufacturer Narrative
The device was not returned for evaluation.A potential root cause for this failure mode could be ¿patient sensitivity to materials¿.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the clean cath vinyl catheter ifus are found to be adequate based on past reviews.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.
Event or Problem Description
It was reported that the customer allegedly experienced frequent utis with use of this catheter.

• Brand Name: BARD® CLEAN-CATH® 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: 9122853
• Report Number: 1018233-2019-05955
• Device Sequence Number: 14157961
• Product Code: KOD
• UDI-Device Identifier: 00801741038976
• UDI-Public: (01)00801741038976
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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?: Yes
• 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: 09/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 09/26/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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: Required Intervention