MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE

Model Number	31G X 5MM
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The patient called in stating that the pen needle clogs during his injection.He stated that he has been using droplet for years and has never had an issue; however, with this box the clog has happened 4-5 times this week.He did not want to provide medical information.He just wanted to let the issue be known.

• Brand Name: DROPLET PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• MDR Report Key: 11751897
• Report Number: 9613304-2021-00013
• Device Sequence Number: 4244456
• Product Code: FMI
• UDI-Device Identifier: 05907996093052
• UDI-Public: (01)05907996093052(17)240701(10)Z56L3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K143437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2024
• Device Model Number: 31G X 5MM
• Device Catalogue Number: 8310
• Device Lot Number: Z56L3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2021
• Initial Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1