MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® SERUM BLOOD COLLECTION TUBES; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367815

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/29/2018

Event Type  malfunction  

Event Description

Red top tube with a bug or something in the tube prior to collection.Another specimen was found from the same lot.

• Brand Name: BD VACUTAINER® SERUM BLOOD COLLECTION TUBES
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 150 s 1st ave; broken bow NE 68822
• MDR Report Key: 8189073
• MDR Text Key: 131156870
• Report Number: 8189073
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367815
• Device Catalogue Number: 367815
• Device Lot Number: 8226915
• 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: 12/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 12/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1