MAUDE Adverse Event Report: BD BD VACUTAINER 21G BUTTERFLY NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 3160334

Patient Problems Needle Stick/Puncture (2462); Device Embedded In Tissue or Plaque (3165)

Event Date 01/04/2024

Event Type  Injury  

Event Description

Bd vacutainer 21g butterfly needle used to draw blood on a patient in ac vein.When needle was being removed from patient, it was noted to be stuck in the patient.A provider was asked for assistance to remove from the patient's skin.Needle was removed and the tip of the needle was found to have a curve to the end causing it to be difficult to remove easily.

• Brand Name: BD VACUTAINER 21G BUTTERFLY NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD
• MDR Report Key: 18517796
• MDR Text Key: 333024032
• Report Number: MW5150201
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3160334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Sex: Female
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White