MAUDE Adverse Event Report: C.R. BARD, INC. INFECTION CONTROL URINE DRAINAGE BAG WITH ANTI-REFLUX CHAMBE; URINARY DRAINAGE BAG

Model Number 154005A

Device Problem Material Discolored (1170)

Patient Problem No Information (3190)

Event Date 09/22/2014

Event Type  No Answer Provided  

Event Description

The nurse noticed during morning report that the drain tube on the patient's urinary drainage bag was discolored a purplish red.Concerned that the patient had blood in his urine, the nurse opened the drain bag and took a sample for a urinalysis.The urine in the drain bag was golden and the urinalysis came back with no blood found in the urine.At that point it was determined that the drain tube was stained from an unknown source.The urinary drainage bag was changed.

• Brand Name: INFECTION CONTROL URINE DRAINAGE BAG WITH ANTI-REFLUX CHAMBE
• Type of Device: URINARY DRAINAGE BAG
• Manufacturer (Section D): C.R. BARD, INC.; 730 central ave.; murray hill NJ 07974
• MDR Report Key: 4172938
• MDR Text Key: 5102185
• Report Number: 4172938
• Device Sequence Number: 1
• Product Code: FCN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: *
• Device Operator: Invalid Data
• Device Model Number: 154005A
• Device Catalogue Number: 154005A
• Device Lot Number: NGYE0339
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/25/2014
• Event Location: Hospital
• Date Report to Manufacturer: 10/15/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IV PUMP, COMPRESSION SLEEVES
• Patient Age: 46 YR
• Patient Weight: 70