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

Device Problems Patient-Device Incompatibility (2682); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Sepsis (2067); Skin Irritation (2076); Patient Problem/Medical Problem (2688)

Event Type  Injury  

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 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.

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 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
• Type of Device: BARDEX COUDE TIP CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8541771
• MDR Text Key: 142876206
• Report Number: 1018233-2019-02120
• Device Sequence Number: 1
• Product Code: MJC
• UDI-Device Identifier: 00801741016974
• UDI-Public: (01)00801741016974
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,distributor,other
• Type of Report: Initial,Followup
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 0168SI18
• Device Catalogue Number: 0168SI18
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization