MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 32G 4MM PRO 100 BOX 1200 US; Needle, hypodermic, single lumen

Model Number 320550

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Event Description

Consumer reported when doing the injection into site, finding the insulin to leak out of the non patient end and pen.Informed caller to do a flow check before injections.Dc consumer reported finding the dose button hard to press down on injections.Consumer reported the pateint end needle bends while injecting lot # 3115878 catalog# 320550 date of event unknown sample status awiaiting sample - unused from this box.Cs0070018/(b)(6).

• Brand Name: PEN NDL 32G 4MM PRO 100 BOX 1200 US
• 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: 18920468
• MDR Text Key: 337855648
• Report Number: 9616656-2024-05157
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• 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: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 320550
• Device Lot Number: 3115878
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1