MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX I.C. COMPLETE CARE URINE METER FOLEY TRAY; DRAIN BAG 1532300J IS PART OF THE TRAY 66300J14

Catalog Number 903014A

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the urine leaked from the catheter immediately on the day of placement.Per additional information via email from ibc on 15feb2021, it seemed that there was no obvious damage.

Manufacturer Narrative

Per additional information received, it has been determined that this mdr event is not reportable.H11: section a through f - the information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the urine leaked from the catheter immediately on the day of placement.Per additional information via email from ibc on 15feb2021, it seemed that there was no obvious damage.Per additional information via email from ibc on 09jul2021, the urine leaked from the drain bag.

• Brand Name: BARDEX I.C. COMPLETE CARE URINE METER FOLEY TRAY
• Type of Device: DRAIN BAG 1532300J IS PART OF THE TRAY 66300J14
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11378967
• MDR Text Key: 233538577
• Report Number: 1018233-2021-00811
• 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: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 903014A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Date Manufacturer Received: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other