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

Model Number	32G X 4MM
Medical Device Problem Codes	Leak/Splash (1354); Improper Flow or Infusion (2954)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Last night my 15u (150ul at 100uper ml) pen injection using pen needles was not injected s.C.I observed a pool of liquid at the skin surface.Repeated injection with a new droplet pen needles and same liquid pooling was noted.I replaced the droplet needles a third time and again observed a liquid pool on my skin at the injection site.All pen needle injections were inserted to the full 4mm depth s.C.Before depressing plunger slowly and waiting over 15 seconds to withdraw pen needle after dosing.It appeared no lantus insulin was injected based on volume of liquid pooling on skin at injection site.Problem with droplet needles.Some (possible all) have restricted inner diameter and do not deliver does s.C.Other appear to leak at plastic pen needle tip.The full dose is not being dosed s.S.But it is not coming back out of the sub cutaneous tissue.It appears to be leaking from pen needle body.

• 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: 12340990
• Report Number: 9613304-2021-00026
• Device Sequence Number: 19767316
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)260401(10)B58F3
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K171982
• 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): 07/27/2021

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: 04/01/2026
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: B58F3
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2021
• Initial Report FDA Received Date: 08/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1