MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA; Needle, hypodermic, single lumen

Model Number 329515

Device Problem Misconnection (1399)

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

Event Date 02/16/2024

Event Type  malfunction  

Event Description

Medical professional reported on behalf of her assisted living facility patient - the non patient end gives the patient difficulty placing onto the insulin pen.Removes autoshield pen needle away from pen the then orange safety covers moves out and over the non patient needle.Consumer cannot use this needle.Lot # 3205100.Catalog# 329515 = 10 needles from this box with this incident.Date of event 02.16.2024.Sample status awaiting sample - unopened samples from this box.(b)(4).

Manufacturer Narrative

10 pen needles affected by this event.

• Brand Name: PEN NEEDLE AUTOSHIELD DUO 30GX5MM USA
• Type of Device: Needle, hypodermic, single lumen
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18903409
• MDR Text Key: 337661907
• Report Number: 9616656-2024-05152
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903295159
• UDI-Public: 00382903295159
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K223286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 329515
• Device Lot Number: 3205100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/24/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1