MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. CARSON MODEL COUDE TIP FOLEY CATHETER; BARDEX COUDE TIP CATHETER

Model Number	0168SI18
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Sepsis (2067); Skin Irritation (2076); Patient Problem/Medical Problem (2688)
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 silver coating on the catheter did not work for the patient.Reportedly, the patient ended up in the hospital, where he was found to be septic.
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: ¿visually inspect the product for any imperfections or surface deteriorations prior to use.".
Event or Problem Description
It was reported that the silver coating on the catheter did not work for the patient.Reportedly, the patient ended up in the hospital, where he was found to be septic.

• Brand Name: BARDEX® I.C. CARSON MODEL COUDE TIP FOLEY CATHETER
• Common Device Name: BARDEX COUDE TIP CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8541771
• Report Number: 1018233-2019-02120
• Device Sequence Number: 2457875
• Product Code: MJC
• UDI-Device Identifier: 00801741016974
• UDI-Public: (01)00801741016974
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• 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
• Report Date (Section B): 05/23/2019

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: 0168SI18
• Device Catalogue Number: 0168SI18
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/23/2019
• Supplement Report FDA Received Date: 05/23/2019
• 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: Hospitalization