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

Model Number 806518

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Purulent Discharge (1812); Erythema (1840); Hemorrhage/Bleeding (1888); Hypersensitivity/Allergic reaction (1907); Discharge (2225); Reaction (2414)

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 patient had a latex allergy, and was switched to silicone catheters.Allegedly, the patient started experiencing a similar reaction with the silicone catheter for the past month.The area around the insertion site of the catheter turned red and was oozing pus and blood.The patient was treated with antibiotics from the doctor.

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 deterioration prior to use.".

Event Description

It was reported that the patient had a latex allergy, and was switched to silicone catheters.Allegedly, the patient started experiencing a similar reaction with the silicone catheter for the past month.The area around the insertion site of the catheter turned red and was oozing pus and blood.The patient was treated with antibiotics from the doctor.

• Brand Name: BARDIA® ALL-SILICONE FOLEY CATHETER
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8060696
• MDR Text Key: 126915194
• Report Number: 1018233-2018-05304
• Device Sequence Number: 0
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 806518
• Device Catalogue Number: 806518
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 11/12/2018
• Supplement Dates Manufacturer Received: 11/13/2018
• Supplement Dates FDA Received: 12/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention