MAUDE Adverse Event Report: HTL-STREFA S.A. DROPLET PEN NEEDLE 32GX4MM

Model Number	32GX4MM
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Patients mother called in today because, her (b)(6) daughter has had several issues since switching from another brand to droplet.Her issues are as followed: she is unable to unscrew the pn from the pen without the use of her fingers.This has happened 100/100x.2/100 the pn had broken off into the pens hub.4/100 the pn has bent upon injecting which prevents insulin flow.We went over the ifu and she states she is doing it correctly and never had such issues with another brand.
Event or Problem Description
Patients mother called in today because, her (b)(6) daughter has had several issues since switching from another brand to droplet.Her issues are as followed: she is unable to unscrew the pn from the pen without the use of her fingers.This has happened 100/100x.2/100 the pn had broken off into the pens hub.4/100 the pn has bent upon injecting which prevents insulin flow.We went over the ifu and she states she is doing it correctly and never had such issues with another brand.

• Brand Name: DROPLET PEN NEEDLE 32GX4MM
• Common Device Name: 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: 13051953
• Report Number: 9613304-2021-00032
• Device Sequence Number: 3902689
• Product Code: FMI
• UDI-Device Identifier: 05907996092697
• UDI-Public: (01)05907996092697(17)260601(10)B58M6
• 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): 12/02/2021

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: 06/01/2026
• Device Model Number: 32GX4MM
• Device Catalogue Number: 8315
• Device Lot Number: B58M6
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/02/2021
• Initial Report FDA Received Date: 12/21/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female