MAUDE Adverse Event Report: BD AUTOSHIELD DUO; NEEDLE, HYPODERMIC, SINGLE LUMEN

Lot Number 2221523

Device Problems Activation, Positioning or Separation Problem (2906); Material Twisted/Bent (2981)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2023

Event Type  malfunction  

Event Description

Bd autosheild duo insulin pen needle - when trying to administer insulin to patient, the rn noted that she could not press the plunger on the pen and insulin would not administer.Upon further review of the device, the needle was removed from the pen and was bent at a 90 degree angle.The needle was replaced and insulin pen was working properly.Rn did not note to have any difficulty with putting the needle on the pen and was concerned it was bent prior to attaching it to the pen.

• Brand Name: AUTOSHIELD DUO
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BD
• MDR Report Key: 16590369
• MDR Text Key: 311840620
• Report Number: MW5115905
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 2221523
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female