MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® FOLEY TRAY; DRAIN BAG

Catalog Number 900016A

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 10/10/2018

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 into the bag after placement.

Manufacturer Narrative

The reported event was unconfirmed.The evaluation found no abnormalities on the returned sample.Water was introduced through the inlet tube and came out from the urine meter to the drainage bag without difficulty.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: "1.Precautions for use (7) pull the catheter to seat the balloon at the level of the bladder neck and secure placement.(8) keep the drainage bag below the bladder level without touching the floor.(9) connect the lead wire of catheter to temperature monitor with extension cable.(10) secure drainage bag to bed sheet with clip to ensure that there is neither twist nor kink in the cube.".

Event Description

It was reported that there was no urine flow into the bag after placement.

• Brand Name: BARDEX® I.C. COMPLETE CARE® FOLEY TRAY
• Type of Device: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8027800
• MDR Text Key: 125935215
• Report Number: 1018233-2018-05117
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K040658
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2021
• Device Catalogue Number: 900016A
• Device Lot Number: MYCSB761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Date Manufacturer Received: 12/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1