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

Lot Number 9063777

Device Problem Retraction Problem (1536)

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

Event Date 05/11/2019

Event Type  malfunction  

Event Description

Staff nurse was drawing blood with a butterfly retractable needle and the needle did not retract completely after use.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); one becton drive; franklin lakes NJ 07417
• MDR Report Key: 8611374
• MDR Text Key: 145091046
• Report Number: 8611374
• 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
• Report Date: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 9063777
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10585 DA