MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 367342

Device Problems Mechanical Problem (1384); Retraction Problem (1536)

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

Event Date 03/25/2019

Event Type  malfunction  

Event Description

While positioning to stick the patient, bd vacutainer malfunctioned and retracted on its own.

Event Description

While positioning to stick the patient, bd vacutainer malfunctioned and retracted on its own.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 8481967
• MDR Text Key: 140892626
• Report Number: 8481967
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00382903673421
• UDI-Public: (01)00382903673421
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 03/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 8288551
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/25/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1