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 Misconnection (1399)

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

Event Type  malfunction  

Manufacturer Narrative

H3 other text : device not available.

Event Description

Consumer reported, the non patient end will not attach to pen prior to injection.Stated, patient end will bend when taking injection.Lot: 3066011, catalog: 320109, date of event: unknown, samples: no cl.

• 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 DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18976175
• MDR Text Key: 338986571
• Report Number: 9616656-2024-05177
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 3066011
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1