MAUDE Adverse Event Report: BD MEDICAL DIABETES CARE BD MEDICAL BLOOD TUBING ; TUBING, FLUID DELIVERY

Lot Number (10)18086026

Device Problem Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Event Description

Blood tubing failures - product defect; 10 different events between (b)(6) - (b)(6) 2018.Date: (b)(6) 2018, 7ne, blood seeping from non-used y spike on tubing above chamber.Lot: (10)18086026, no pt harm, (b)(4).Ref #'s mw5083033, mw5083035, mw5083036, mw5083037, mw5083038, mw5083039, mw5083040, mw5083041, and mw5083042.

• Brand Name: BD MEDICAL BLOOD TUBING
• Type of Device: TUBING, FLUID DELIVERY
• Manufacturer (Section D): BD MEDICAL DIABETES CARE
• MDR Report Key: 8239496
• MDR Text Key: 133057662
• Report Number: MW5083034
• Device Sequence Number: 1
• Product Code: FPK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: (10)18086026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other