MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® FOLEY TRAY WITH BARD HYDROPHILIC-COATED FOLEY CATHETER; COMPONENT (FOLEY TRAY)

Catalog Number 898314

Device Problems Gel Leak (1267); Leak/Splash (1354)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.

Event Description

It was reported that the pvi leaked inside the tray, this was found before use.

Manufacturer Narrative

The reported event was confirmed as supplier related.The evaluation found a void/channel at the edge of the pvi sachet causing the pvi solution to leak out.The reported event could have been contributed by the supplier.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: "[storage method and expiration date] 1.Storage store in a dry, cool place away from heat, moisture, and direct sunlight.2.Expiration date indicated on the direct package and the outer box.".

Event Description

It was reported that the pvi leaked inside the tray, this was found before use.

• Brand Name: BARD® FOLEY TRAY WITH BARD HYDROPHILIC-COATED FOLEY CATHETER
• Type of Device: COMPONENT (FOLEY TRAY)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8446122
• MDR Text Key: 139688569
• Report Number: 1018233-2019-01502
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 898314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/22/2019
• Supplement Dates Manufacturer Received: 04/30/2019
• Supplement Dates FDA Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1