MAUDE Adverse Event Report: BD BD VACUTAINER 2.7 ML BLUE TOP TUBE; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Lot Number 9220391

Device Problem Suction Problem (2170)

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

Event Type  malfunction  

Event Description

Bd vacutainer 2.7ml blue top tubes overfill.This causes the pt to have to be redrawn.The suction in the tube is too much and pulls too much blood.Fda safety report id# (b)(4).

• Brand Name: BD VACUTAINER 2.7 ML BLUE TOP TUBE
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BD
• MDR Report Key: 9641995
• MDR Text Key: 177160679
• Report Number: MW5092606
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Lot Number: 9220391
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/28/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1