MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER; URINE DRAINAGE BAG (CONOD)

Catalog Number 902814

Device Problem Gel Leak (1267)

Patient Problem No Patient Involvement (2645)

Event Date 08/16/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed as contributed by supplier.Observed jelly was leakage due to the sealing of jelly sachet was not properly sealed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "[directions for use] 1.Method of use the device is intended for single use only and is not reusable.Cleanse the area around the external urethral meatus with the cotton balls immersed in the antiseptics.Lubricate the distal end of the catheter with water-soluble lubricant packaged in the tray.".

Event Description

It was reported that urine leaked from somewhere on the urine bag.The duration of use was not reported.Per email received from the ibc representative on 4-sept-19, the actual event was that jelly pocket was empty prior to use.Per email received from the ibc representative on 4-sept-19, based on evaluation there were found the lubricant jelly leakage from the sachet due to sealing area was not sealed properly.

• Brand Name: BARD® URINE METER FOLEY TRAY WITH BARDEX® LUBRICATH® FOLEY CATHETER
• Type of Device: URINE DRAINAGE BAG (CONOD)
• 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: 9124464
• MDR Text Key: 196259610
• Report Number: 1018233-2019-05996
• Device Sequence Number: 1
• Product Code: EZC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K910846
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/26/2019

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 Expiration Date: 01/01/2022
• Device Catalogue Number: 902814
• Device Lot Number: MYCVB957
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2018
• 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