MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367344

Patient Problem Pain (1994)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

During blood draws, patients are complaining of more painful pokes.Lab personal have also noticed a resistance on the skin while poking patients.The bevel looks to be smaller and angled differently than other lots.

• Brand Name: BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET
• Type of Device: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 19018550
• MDR Text Key: 339104501
• Report Number: 19018550
• Device Sequence Number: 1
• Product Code: JKA
• 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: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 367344
• Device Catalogue Number: 367344
• Device Lot Number: 3153452
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2024
• Date Report to Manufacturer: 04/02/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2024
• Type of Device Usage: Unknown
• Patient Sequence Number: 1