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

Model Number 367986

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2018

Event Type  malfunction  

Event Description

There was no patient involvement, however, it was noted that a new specimen tube which was pulled for a blood sample contained a wooden stick shard in the gel matrix.The blood tube was not utilized on a patient.None of the other vials in the set/lot had any issues and this hospital has no other of the same lot in the lab.

• Brand Name: BD VACUTAINER® SST¿
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 8309906
• MDR Text Key: 135181717
• Report Number: 8309906
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 367986
• Device Catalogue Number: 367986
• Device Lot Number: 8162632-2016-05-31
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2019
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1