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

Model Number 32G X 4MM

Device Problems Leak/Splash (1354); Improper Flow or Infusion (2954)

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

Event Type  malfunction  

Event 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
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer (Section G): HTL-STREFA S.A.; adamowek 7; ozorkow, 95-03 5; PL 95-035
• Manufacturer Contact: justyna zemigala ; adamowek 7; ozorkow, 95-03-5 ; PL 95-035
• MDR Report Key: 12340990
• MDR Text Key: 267248517
• Report Number: 9613304-2021-00026
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)260401(10)B58F3
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171982
• 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: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 32G X 4MM
• Device Catalogue Number: 8315
• Device Lot Number: B58F3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1