MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDIA® ALL-SILICONE FOLEY CATHETER; SILICONE CATHETER

Model Number	806316
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Bacterial Infection (1735); Unspecified Infection (1930); 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.The device was not returned.
Event or Problem Description
It was reported that the patient experienced frequent bacterial and urinary tract infections from using the silicone catheter.The patient was reportedly prescribed with antibiotics to treat the 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: ¿sterile, unless package is opened or damaged.".
Event or Problem Description
It was reported that the patient experienced frequent bacterial and urinary tract infections from using the silicone catheter.The patient was reportedly prescribed with antibiotics to treat the infection.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9371211
• Report Number: 1018233-2019-07524
• Device Sequence Number: 2223906
• Product Code: EZL
• UDI-Device Identifier: 00801741039119
• UDI-Public: (01)00801741039119
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• 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): 12/10/2019

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: 806316
• Device Catalogue Number: 806316
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/05/2019
• Supplement Date Received by Manufacturer: 12/04/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/10/2019
• 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