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

Model Number 367342

Device Problem Retraction Problem (1536)

Patient Problem Insufficient Information (4580)

Event Date 09/17/2020

Event Type  malfunction  

Event Description

Phleb completed draw and safety device malfunctioned and did not completely retract the needle.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 10566115
• MDR Text Key: 207921974
• Report Number: 10566115
• Device Sequence Number: 1
• Product Code: FPA
• 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: 09/21/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 0125355
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/21/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/22/2020
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown