MAUDE Adverse Event Report: BECTON DICKINSON CO VACUTAINER; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367344

Device Problems Crack (1135); Leak/Splash (1354); Suction Problem (2170)

Patient Problem Blood Loss (2597)

Event Date 11/24/2014

Event Type  malfunction  

Event Description

Cracks found in plastic at end of tubing.Suction not working, blood leaked out.Blood draw had to be done over.

• Brand Name: VACUTAINER
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON DICKINSON CO; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 4371744
• MDR Text Key: 5112066
• Report Number: 4371744
• Device Sequence Number: 1
• Product Code: JKA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 12/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367344
• Device Lot Number: 4107814
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/11/2014
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/30/2014
• Patient Sequence Number: 1