MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD VACUTAINER#174; PUSH BUTTON BLOOD COLLECTION SET; TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Model Number 367344

Patient Problem Pain (1994)

Event Date 10/24/2023

Event Type  malfunction  

Event Description

When drawing blood from a patient, when needle was poked into patient's skin, the blood drawer felt resistance and the patient felt more pain with the poke.Further look at the needle the bevel looks different compared to other needles of different lots.

• Brand Name: BD VACUTAINER#174; 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: 18290542
• MDR Text Key: 330040923
• Report Number: 18290542
• 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: 11/21/2023

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 Operator: Other
• 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: 11/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/08/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/08/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1