MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 31GA 8MM 100 BX 1200 USA; Needle, hypodermic, single lumen

Model Number 320109

Device Problem Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not available.

Event Description

Consumer reported leaking from non patient end while completing the injections.Consumer reported the needles also does not attach or fit onto his baslagar pen either.Dc lot # 3087250.Catalog# 320109.Date of event unknown.Sample status discard.Cs0070076/00018915.

• Brand Name: PEN NDL 31GA 8MM 100 BX 1200 USA
• Type of Device: Needle, hypodermic, single lumen
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• Manufacturer (Section G): BECTON AND DICKINSON CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18949093
• MDR Text Key: 338987858
• Report Number: 9616656-2024-05165
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903201099
• UDI-Public: 382903201099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213478
• 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: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 320109
• Device Lot Number: 3087250
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1