MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BECTON DICKINSON; VACUTAINER

Model Number 21G

Device Problem Hole In Material (1293)

Patient Problem No Information (3190)

Event Date 05/02/2018

Event Type  malfunction  

Event Description

Multiple holes/tears in tubing of vacutainer.

• Brand Name: BECTON DICKINSON
• Type of Device: VACUTAINER
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY
• MDR Report Key: 7506331
• MDR Text Key: 108229955
• Report Number: MW5077153
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903686520
• UDI-Public: 00382903686520
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21G
• Device Catalogue Number: 368652
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 11 YR
• Patient Weight: 94