MAUDE Adverse Event Report: BECTON DICKINSON & CO. PEN NEEDLE UF MINI 31GX5MM; NEEDLE, HYPODERMIC, SINGLE LUMEN

Device Problems Improper or Incorrect Procedure or Method (2017); Material Twisted/Bent (2981)

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

Event Date 05/08/2023

Event Type  Injury  

Event Description

Some of the pen needles the patient received were bent.Due to this the patient reused some pen needles.

• Brand Name: PEN NEEDLE UF MINI 31GX5MM
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON & CO.
• MDR Report Key: 17004251
• MDR Text Key: 316052161
• Report Number: MW5117855
• 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: Patient
• Type of Report: Initial
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Expiration Date: 04/17/2024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Female