MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY; DRAINAGE BAG (CONOD)

Catalog Number 919414A

Device Problems Restricted Flow rate (1248); No Flow (2991)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2018

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 there was no urine flow from the outlet tube of the bag.

Manufacturer Narrative

The reported event was confirmed as manufacture related.The evaluation found nipple base adhered to white vinyl of the bag.It was observed that the water flow was slow.How and when problem occurred could not be determine.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: "(24) do not pull or twist the outlet tube.Also, do not squeeze the drainage bag.[the joint of the drainage bag and the outlet tube may be damage and urine leakage may occur.] (25) when disposing of urine, observe the following: 1) remove the outlet tube from the housing of the urine drainage bag.2) lift the green lever to open while holding the outlet tube.Be careful not to pull the outlet tube when lifting the green lever.3) when disposal of urine is completed, close the green lever and put the outlet tube into the housing.".

Event Description

It was reported that there was no urine flow from the outlet tube of the bag.

Event Description

It was reported that there was no urine flow from the outlet tube of the bag.Per sample evaluation, the nipple base was adhered to the white vinyl of the bag causing the water to flow out slowly.

Manufacturer Narrative

Upon further review, bard/bd has determined that this mdr was initially reported in error as this event is not reportable.

• Brand Name: BARDEX® I.C. COMPLETE CARE® TEMPERATURE-SENSING URINE METER FOLEY TRAY
• Type of Device: DRAINAGE BAG (CONOD)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8150757
• MDR Text Key: 130060889
• Report Number: 1018233-2018-05962
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 919414A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2018
• Date Manufacturer Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1