MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET SET, ADMINISTRATION, INTRAVASCULAR

Model Number 367342

Device Problem Retraction Problem (1536)

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

Event Date 08/23/2018

Event Type  malfunction  

Event Description

Bd vacutainer push button blood collection set 23g 3/4", needle is self retracting while inserted in vein.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport rd; sumter SC 29153
• MDR Report Key: 7854717
• MDR Text Key: 119498049
• Report Number: 7854717
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 367342
• Device Catalogue Number: 367342
• Device Lot Number: 8071903
• 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: 08/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2018
• 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?: No

Type of Device Usage

Patient Treatment Data

Date Received: 09/07/2018 Patient Sequence Number: 1