MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® BUFF. NA CITRATE 0.109M, 3.2%; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 363080

Device Problem Suction Problem (2170)

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

Event Date 10/01/2019

Event Type  malfunction  

Event Description

The 1.8 ml tubes do not appear to have enough suction to fill to the required minimum on a variety of lot numbers.

• Brand Name: BD VACUTAINER® BUFF. NA CITRATE 0.109M, 3.2%
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 9250137
• MDR Text Key: 164139335
• Report Number: 9250137
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/04/2019

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 Model Number: 363080
• Device Catalogue Number: 363080
• Device Lot Number: 9184798 AND 9168667
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/04/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1