MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® CENTER ENTRY FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER; UINKNOWN FOLEY TRAY

Catalog Number 897416

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 states the following: do not disconnect, pull on, or twist your catheter or drainage bag tubing.If you notice leaks in the system, notify your nurse immediately.Keep the drainage bag below the level of your bladder at all times.Do not place the drainage bag on it's side-always keep the bag in an upright position.Do not empty the drainage bag yourself.*notify your nurse i the bag becomes full.The device was not returned.

Event Description

It was reported that the tray did not have the betadine packet included.No medical intervention was report.

• Brand Name: BARD® CENTER ENTRY FOLEY TRAY WITH BARDEX® ALL SILICONE FOLEY CATHETER
• Type of Device: UINKNOWN FOLEY TRAY
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 8760265
• MDR Text Key: 151589788
• Report Number: 1018233-2019-03618
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/03/2019

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: 897416
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1